Decentralized Clinical Trials Archives

Regulatory Affairs-Interview Questions & Answers

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Regulatory Affairs in the Pharmaceutical industry is a profession that acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing. What are the goals of Regulatory Affairs Professionals? What are the Roles of Regulatory Affairs professionals? What is an Investigational New Drug (IND) application? It is an application that is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA What is a New Drug Application? The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDAIn simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in the USA” What is an Abbreviated New Drug Application (ANDA)? It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug.In simple words, “It is an application for the approval of Generic Drugs “ What is a Generic Drug Product? A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use. What is a DMF? A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.Important facts regarding DMFs· It is submitted to FDA to provide confidential information· Its submission is not required by law or regulations· It is neither approved nor disapproved· It is filed with FDA to support NDA, IND, ANDA another DMF, or amendments and supplements toany of these· It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420· It is not required when the applicant references its own information What are the types of DMFs? Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or DrugProductType III: Packaging MaterialType IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their PreparationType V: FDA Accepted Reference Information (FDA discourages its use) What is a 505 (b) (2) application? 505 (b)(2) application is a type of NDA for which one or more investigations relied on by the applicant for approval were not conducted by/for the applicant and for which the applicant has not obtained a right of reference. What kind of application can be submitted as a 505(b)(2) application? What are the examples of changes to approved drug products for which 505(b)(2) applicationshould be submitted? What are the chemical classification codes for NDA? What are the differences between NDA and 505 (b)(2) application? New Drug Application (NDA) 505 (b)(2) Application All investigations relied on by the applicant for approval were conducted by/for the applicant and for which the applicant has the right of reference One or more investigations relied on by the applicant for approval were not conducted by/for the applicant and for which the applicant has not obtained a right of reference Generally, filed for newly invented pharmaceuticals. Generally, filed for new dosage form, new route of administration, new indication, etc for all already approved pharmaceuticals. Note: 505 (b)(2) application is a type of NDA. What is a Marketing Authorization Application? It is an application filed with the relevant authority in Europe (typically, the UK’s MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine. As per UK’s MHRAApplications for new active substances are described as ‘full applications’. Applications for medicines containing existing active substances are described as ‘abbreviated’ or ‘abridged applications’. What is an ASMF? An active substance master file is a submission that is made to EMA, MHRA, or any other Drug Regulatory Authority in Europe to provide a confidential intellectual property or ‘know-how’ of the manufacturer of the active substance. In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active Pharmaceutical Ingredient (API)”. What are the types of active substances for which ASMFs are submitted? What is the difference between DMF and ASMF (concerning submission)? ASMF is submitted as Applicant’s Part (Open Part) and Restricted Part (Closed Part) There isn’t any differentiation of DMFs into parts What is ICH? International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a project that brings together the regulatory authorities of Europe, Japan, and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. What is CTD? The Common Technical Document (CTD) is a set of specifications for the application dossier, for the registration of Medicines and is designed to be used across Europe, Japan, and the United States. Quality, Safety, and Efficacy information are assembled in a common format through CTD. The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration ofPharmaceuticals for Human Use (ICH). CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia, etc. What are the ICH guidelines to be referred to for the preparation of registration dossiers/applications of medicines (With respect to format and contents in each module)? What are the modules in CTD? What is Orange Book? It is the commonly used name for the book “Approved Drug Products with Therapeutic Equivalence Evaluations”, which is published by USFDA. It contains the list of drug products, approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food,

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Mastering the Art of Job Application Emails: 12 Templates and Tips

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In today’s competitive job market, standing out to potential employers is more crucial than ever. One of the first hurdles in the job application process is crafting an email that not only captures the attention of hiring managers but also convincingly conveys your suitability for the role. Whether you’re a recent graduate, a seasoned professional, or transitioning careers, mastering the art of the job application email is an essential skill. Below, we offer 12 customizable templates and invaluable tips to help you make a memorable first impression.

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Source documentation in clinical trials

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We all have heard this saying “If it’s not documented, it didn’t happen” concerning clinical trials. But the question is for clinical trials what is to be documented and how? Today we will walk through insights about source documents in clinical research. Source means originality. Source documents are original documents, data, or records that are created during a clinical study trial. Source documents are essential documents that are required by regulatory and GCP guidelines. There are Source Documents of 2 types: Electronic Source Data which is audio, pictorial, text, graphics, reports, or other information created in digital form that is modified, maintained, archived, or retrieved by a computer system or electronic system. Requirements for Electronic Source Documents:1) Computer system (validation)2) Electronic records (audit trail)3) Electronic signatures4) Users and technical support Guidelines :21 CFR Part 11 Guidelines; Electronic Records – Electronic signatures (1997)Guidance for Industry: Part 11, Electronic Records; Electronic Signatures GuidelinesScope and Application (2003)Guidance for Industry: Computerized Systems Used in ClinicalInvestigations (2007)Electronic Source Data in Clinical Investigations – (2013) Guidance for Industry Paper Source Handwritten data are prepared on the pre-printed forms.Handwritten source documents are either handwritten or printed documents (pre-filled), with the original handwritten Investigator’s signature. The following aspects should be taken into consideration while selecting source documents: Documents which are considered as Source Documentation: Purpose of Source documentation: Source Document Verification (SDV) The main challenges during SDV are: Documentation should be able to provide an audit trail to permit investigation if and when required. Key attributes for good documentation practice described in the form of ALCOA & ALCOA+ – attributable, legible, contemporaneous, original and accurate. ALCOA+ is with few more concepts which are complete, consistent, enduring, available. Some qualities of Good documentation practices defined by USFDA and EMEA are as follows: It should be clear who has performed the action and documented the data. Attributable The information should be documented at the correct time frame when the action performed along with the flow of events. An acceptable amount of delay should be defined and justified remark. Original, or authorised true copy, the first record which is made by the designated person. The investigator should have the record of original source document. Accurate, consistent and real representation of facts. Long-lasting and durable. Easily available and accessible for review or present of data during audits/inspections. The documents should be retrievable in a reasonable time. Complete till that point in time. Demonstrate the required attributes consistently. Based on real and reliable facts. The data should be backed up by evidence. Data can be captured electronically by the following ways: References: Content : Pooja Parab

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What is an Investigator Site File (ISF)

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In the context of clinical trials, ISF stands for “Investigator Site File,” which is a collection of documents and records that are maintained by the clinical trial site or investigator. The ISF contains all essential documents that demonstrate compliance with Good Clinical Practice (GCP) guidelines, applicable regulations, and study-specific protocols. The ISF binder is a physical or electronic folder that contains all the documents that make up the Investigator Site File. The ISF binder serves as a central repository for all study-related documents, including the signed informed consent forms, ethics committee approval letters, study protocols and amendments, participant medical records, and other important trial-related documents. The ISF binder is typically maintained by the clinical trial site or investigator and must be kept up-to-date throughout the study. The binder is often audited by sponsors, regulatory authorities, and independent review boards to ensure that the trial is being conducted in compliance with applicable regulations and guidelines. The Investigator Site File (ISF) is a critical component of clinical trials. It is a comprehensive collection of documents that provide evidence of the compliance of the clinical trial site with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study-specific protocols. The ISF binder is a physical or electronic folder that contains all the essential documents that make up the Investigator Site File. In this article, we will discuss the uses, examples, and electronic ISF of the ISF binder in clinical trials. Why ISF Binder in Clinical Trials? The ISF binder plays an essential role in the management of clinical trials. It serves as the central repository for all the documents that are necessary to demonstrate the compliance of the clinical trial site with GCP guidelines, regulatory requirements, and study-specific protocols. The following are the key uses of the ISF binder in clinical trials: The ISF binder contains all the documents that demonstrate compliance with GCP guidelines, regulatory requirements, and study-specific protocols. It provides the necessary evidence that the clinical trial site has followed all the procedures and requirements to ensure the safety, rights, and well-being of the study participants. The ISF binder is the primary source of documentation for regulatory authorities, sponsors, and independent review boards to verify the conduct of the clinical trial. It facilitates audits and inspections and ensures that the study site is maintaining accurate and complete records. The ISF binder contains all the documents that are necessary to verify the accuracy, completeness, and validity of the clinical trial data. It helps to ensure that the data collected during the study is of high quality and can be used for statistical analysis and reporting. Examples of Documents in ISF Binder: The ISF binder contains a range of documents that provide evidence of the compliance of the clinical trial site with GCP guidelines, regulatory requirements, and study-specific protocols. The following are some examples of documents that are typically included in the ISF binder: The study protocol is the primary document that outlines the objectives, methodology, and procedures of the clinical trial. It is a critical document that provides the framework for the conduct of the study. Any amendments made to the study protocol are also included in the ISF binder. The informed consent form is a document that explains the nature of the study, the procedures involved, and the risks and benefits of participation. It also outlines the participant’s rights and obligations during the study. The signed informed consent form of each participant is included in the ISF binder. Before a clinical trial can begin, it must receive approval from an independent ethics committee or institutional review board. The approval letter from the ethics committee is included in the ISF binder to demonstrate that the clinical trial site has obtained the necessary approvals to conduct the study. The Investigator Brochure is a document that provides information about the investigational product being tested in the clinical trial. It contains information about the pharmacology, toxicology, and clinical experience of the product. The Investigator Brochure is included in the ISF binder to provide the necessary information about the investigational product to the clinical trial site. The participant medical records contain information about the health status, medical history, and test results of the study participants. These records are necessary to monitor the safety and well-being of the participants during the study. The participant medical records are included in the ISF binder to provide a comprehensive record of the study participant’s health. Electronic ISF: In clinical trials, the Investigator Site File (ISF) is a critical component that provides evidence of the compliance of the clinical trial site with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study-specific protocols. Traditionally, the ISF has been maintained in a physical binder containing all the necessary documents. However, with the advancement of technology, electronic ISFs have become increasingly popular. In this article, we will discuss what an electronic ISF is, its benefits, and examples of electronic ISFs used in clinical trials. What is an Electronic ISF? An electronic ISF is a digital system that manages all the documents required to demonstrate compliance with GCP guidelines, regulatory requirements, and study-specific protocols. Electronic ISFs typically consist of a secure, web-based platform that allows users to upload, store, and manage documents online. Benefits of Electronic ISF: Electronic ISFs offer several advantages over traditional paper-based systems, including: Electronic ISFs reduce the time and effort required to maintain and manage the documents. Since electronic ISFs are digital, users can easily upload and manage documents from any location with an internet connection. This eliminates the need to maintain physical copies of documents, which can be time-consuming and prone to errors. Electronic ISFs are accessible to all authorized users at any time, from anywhere. This means that clinical trial team members can access the documents they need quickly and easily, without having to physically locate the ISF binder. Electronic ISFs provide enhanced security features such as access control, audit trails, and encryption. This ensures that sensitive information is protected and that only authorized personnel can access the documents.

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Electronic Trial Master File

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Electronic trial master file (eTMF) is an electronic mode of collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. It is the story of how the trial was conducted and managed. Management of essential trial documentation is undoubtedly one of the most time-consuming and costly activities associated with conducting a clinical trial. A Trial Master file should present a historical look at the actions that have been taken throughout a clinical trial. A well-kept TMF can help with efficient trial management and can facilitate the reconstruction of the conduct of the trial during the audit or inspection process. Most paper-based industries and processes have matured and benefited from some kind of digital transformation. A variety of document management software has made workplace processes far more efficient. Legal, healthcare, IT, and Financial industries along with numerous other industries have all leveraged software technologies to impact the efficiency and effectiveness of their processes. The pharmaceutical and biotech industry is no different. Need for the digitization of TMF Until recently, before Information Technology (IT) became prominent in the research and medical field, managing Clinical trial regulatory documents had been paper-based. The size and complexity of a TMF were in direct proportion to the length and complexity of the trial. Paper-based processes were laborious, costly, and prone to errors. Providing a digital platform and strategy around the capture, management, and reporting of regulatory documents was necessary to enable clinical trial stakeholders to be more productive, and effective, and reduce business risk. Also, the format of a TMF, the content names, and requirements varied from sponsor to sponsor, creating a high degree of variability and inconsistency. Electronic Trial Master File (eTMF) An industry-wide momentum to streamline clinical trial processes and adopt applications to improve operational efficiency resulted in the adoption of digital processes to create and manage TMFs. A way of capturing, managing, sharing, and storing those essential documents and content from a clinical trial in a digital format is called an electronic master file or eTMF. In simple terms, it is a Trial Master File in electronic or digital format. It is a specialized content management system used to manage clinical documents across the life cycle of a clinical trial. An eTMF system automates manual paper-based Trial Master File processes. The International Conference on Harmonization (ICH) has defined a set of guidelines on Good Clinical Practice (GCP) and each TMF should adhere to the guidelines defined by ICH. Any eTMF service providing the company should stick to ICH guidelines. Though the format may be different they have to essentially focus on these key items in an e-TMF: Benefits of eTMF Leading eTMF software’s These are the Industry’s top leading eTMF software. Ennov Veeva Vault Qualsys Medidata Phlexglobal Clinevotech Arivis Veristat Florence Capterra Wingspan Future scope of eTMF Pharma and biotechnology companies are investing a lot in digitization. With gaining acceptance of eTMF in clinical trials, increased funding, and a rise in R&D programs by pharma companies, the worldwide eTMF market is expected to show exponential growth over the next decade. The high growth of electronic trial master file (eTMF) can be attributed to the growing number of clinical trials across the globe and government regulations keeping eTMF mandatory for clinical trials. eTMF will soon cease being just a repository to store and manage files. Companies are using Cloud-based models, Artificial Intelligence (AI), Machine Learning, and other high-quality data and document management systems to generate extensive reports. The future aim is to achieve real-time inspection and analysis of data, audit readiness, and on-the-fly report generation. Thank you for reading. Article By : Shahenaz Karadesai.

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What is the difference between paper TMF and eTMF?

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A Traditional Paper Master File (TMF) is a physical collection of documents that are used to store and manage important information related to a clinical trial. These documents are typically stored in binders or folders and are usually kept in a secure location, such as a study site or sponsor’s office. An Electronic Master File (eTMF) is a digital system used to store, manage, and track the progress of important trial-related documents, such as informed consent forms, study protocols, investigator brochures, and regulatory submissions. The eTMF system is designed to replace traditional paper-based systems and improve the efficiency, security, and accessibility of trial-related documents. The main differences between paper TMF and eTMF are as follows: In summary, eTMF is a digital system that improves the efficiency, security, and accessibility of trial-related documents. It allows for easy sharing and collaboration, tracking, and monitoring of the progress of the trial, and is compliant with regulatory requirements. On the other hand, paper TMF is a physical collection of documents that is relatively low-cost but can be difficult to share, collaborate on, track, and monitor. Paper TMF can be inefficient, limit accessibility and collaboration, and increase the risk of damage or loss, which makes it difficult to ensure compliance with regulations. TAGS: CLINICAL RESEARCH, CLINICAL TRIALS, CLINICALRESEARCH, CLINICALRESEARCHCOORDINATOR, CLINICALRESEARCHORGANISATION, CLINICALTRIALS, CRO, ETMF, MEDICALWRITING

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Types of site visits by CRA

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A Clinical Research Associate (CRA) can be employed directly by the sponsor companies (such as Pharmaceutical, Biotechnology, or any research company) of clinical trials or by Contract Research Organizations (CROs), also referred to as Clinical Research Organizations. According to ICH GCP, these organizations conduct clinical trials on behalf of the sponsor companies. Let’s learn about the types of clinical trial site visits conducted by CRAs. The primary responsibility of a CRA is to ensure that the rights, safety, and well-being of subjects participating in clinical trials are protected. The CRA acts as the main mode of communication between sponsors and the site. A Clinical Research Associate qualifies, initiates, monitors, and closes the clinical trial sites assigned to him/her. Based on their level of experience, CRAs can be hired at various levels such as CRA Level I, II, III, and as Senior CRA by employers. Some common on-job responsibilities of CRAs include: Required skills for a Clinical Research Associate include: The process of outsourcing and flow in clinical trials involves: I am listing the types of Clinical Trial Site Visits conducted by CRAs, which may vary depending on industry practices: In conclusion, these are the basic types of Clinical Trial Site Visits conducted by CRAs. I will provide detailed information about each visit in upcoming articles. Article By: Shahenaz Karadesai

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Clinical Research Associate: Roles & Responsibilities

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Introduction Clinical research plays a pivotal role in advancing medical knowledge and patient care. At the heart of this process are Clinical Research Associates (CRAs), professionals who ensure the efficacy and safety of clinical trials. As the pharmaceutical and biotechnology industries expand, so does the demand for skilled CRAs. This blog aims to demystify the roles and responsibilities of a CRA and highlight the significance of this career in the realm of clinical research. A Clinical Research Associate is a professional who monitors the administration and progress of a clinical trial (a research study that tests how well new medical approaches work in people). Typically, CRAs hold a degree in pharmacy, life sciences, nursing, or a related field, combined with substantial knowledge of clinical research protocols. They are the linchpins in the development of drugs, biologics, and medical devices, bridging the gap between the clinical trial process and regulatory compliance. Key Responsibilities of a Clinical Research Associate 1. Site Selection and Preparation CRAs are involved in selecting suitable sites for clinical trials, and assessing the capabilities of a site to conduct the trial. This involves evaluating the staff’s qualifications, the facility’s equipment, and the site’s patient population. They also play a key role in preparing the site for the study, ensuring that each site has the necessary materials and training to conduct the trial according to protocol. 2. Protocol Development and Implementation CRAs contribute to developing the clinical trial protocol, a document that outlines the objectives, design, methodology, statistical considerations, and organization of a trial. They ensure that the trial is implemented as per the protocol and that any deviations are documented and justified. 3. Subject Recruitment and Consent A crucial aspect of a CRA’s role is facilitating the recruitment of subjects for the trial. They ensure that potential subjects are properly informed about the trial and that informed consent is obtained in accordance with regulatory requirements. 4. Monitoring Clinical Trials CRAs regularly visit trial sites to monitor the progress of the trial. They verify that the clinical trial data recorded by investigators is accurate and that the trial is being conducted in compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements. 5. Ensuring Compliance CRAs ensure that clinical trials comply with regulatory standards and ethical guidelines. They are responsible for understanding and keeping up to date with regulations and guidelines, such as those set by the FDA or EMA. 6. Data Management and Reporting Managing and overseeing the data collected during clinical trials is another key responsibility. CRAs review data for accuracy and completeness and assist in preparing reports on the trial’s findings. Challenges Faced by Clinical Research Associates CRAs often face challenges such as managing responsibilities across multiple trial sites, ensuring data integrity, and adapting to constantly changing regulatory environments. Problem-solving skills, adaptability, and a keen eye for detail are essential traits for success in this role. The Future of Clinical Research Associates The role of a CRA is evolving with advancements in technology and changes in the regulatory landscape. CRAs are increasingly involved in virtual or remote monitoring of trials, using digital tools to manage and oversee trial progress. As the field grows, so do the career paths and advancement opportunities for CRAs. Conclusion Clinical Research Associates play a critical role in the success of clinical trials. They ensure that trials are conducted ethically, efficiently, and in compliance with regulatory standards. The role of a CRA is not only challenging and demanding but also highly rewarding, contributing significantly to the advancement of medical research and patient care.

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Clinical Research Coordinator: Role and Responsibilities

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Introduction The role of a Clinical Research Coordinator (CRC) is pivotal in the landscape of clinical trials and research. These professionals are primarily responsible for managing the daily operations of clinical studies, ensuring compliance with regulatory requirements, and maintaining high standards of care and accuracy. Key Responsibilities of a Clinical Research Coordinator A Day in the Life of a Clinical Research Coordinator 8:00 AM: The day starts with a review of the schedule. The CRC checks appointments with study participants and prepares for their arrival. 9:00 AM: A participant arrives for a follow-up visit. The CRC conducts an informed consent process, reviews the participant’s medical history, and answers any questions. 10:30 AM: Time for data entry. The CRC updates the study database with the latest data collected from participant visits. 12:00 PM: Lunch break, often used to catch up on the latest research and developments in clinical trial management. 1:00 PM: The afternoon is dedicated to a team meeting with the principal investigator and other staff. They discuss the progress of the study and address any issues. 2:30 PM: The CRC prepares documents for an upcoming IRB meeting, ensuring that all regulatory aspects of the study are in order. 4:00 PM: A session is held with a new participant for screening. The CRC explains the study protocol, assesses eligibility, and schedules the next visit. 5:30 PM: Before wrapping up, the CRC checks emails and responds to queries from participants and other team members. 6:00 PM: The day ends with a plan for the next day, including participant visits, data analysis, and team coordination. Conclusion A Clinical Research Coordinator plays a vital role in the success of clinical trials, balancing administrative, regulatory, and patient-care responsibilities. Their typical day reflects the diverse and dynamic nature of their job, ensuring the smooth and ethical conduct of clinical research.

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Top Guidance Tips for CLINICAL RESEARCH Freshers

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Amaan Ansari COMPLETED B PHARM FROM NORTH MAHARASHTRA UNIVERSITY, HAVING 3.5+ YEARS OF EXPERIENCE IN CLINICAL DATA MANAGEMENTON A PERSONAL FRONT, I AM KEEN TO HELP AND GUIDE INDIVIDUALS IN CLINICAL DATA MANAGEMENT AND PHARMACOVIGILANCE.ALSO ON GENERAL ASPECTS SUCH AS COMMUNICATION SKILLS, INTERPERSONAL SKILLS, INTERVIEW TIPS, RESUME WRITING, EMAIL WRITING. This content is copied from Amaan Ansari’s LinkedIn posts. Please read the post carefully as Amaan gave some light to a particular topic. Many Life Sciences graduates/postgraduates also Pharm graduates/post graduates especially freshers are looking for opportunities in #clinicaldatamanagement and #pharmacovigilance etc. For entering these fields many individuals are additionally pursuing PG Diploma in CDM and PV and investing thousands of rupees in it. The question here is, are these certificates compulsory to enter these fields?The answer is “No”. If you are pursuing it’s good but it’s not compulsory for entering PV or CDM. As a fresher you just need to:1) Be thorough with your educational background.2) Develop communication skills.3) Gain basic knowledge of CDM and PV through Slide Share ppt, Google ppts. etc.4) Prepare a good CV5)Approach people working in PV and CDM for professional guidance. Remember one or the other day you will be selected. If you are rejected anywhere there is always a better opportunity waiting for you. The majority of Pharmacy and Life Sciences freshers are confused about how to start their careers. How to start your career Below are some important points: If a person is posting any job opportunities from his/her organization it is always as a helping hand. A person will post whatever official email he gets from his organization let it be for freshers/ experience. He can’t post anything from his end. Also if you are eligible for the particular job role the most he/she can do is Refer you and guide you, that’s it what we can do. Getting interview calls and getting selected is not in our hands. I know as a fresher it’s not easy to get a chance. But have faith in yourself and prepare yourself and be the best, hopefully, One day you will get your dream job. So keep learning and Helping each other. I try to reply to every person who DMs me, sometimes due to an overload of DMs there might be a delay in reply, but I assure you that I reply. Please note this is a generic scenario. It may vary from person to person.vI applied for many jobs but no response!! There is always a common question among freshers that we are applying for many job opportunities for the last 5/6 months but we are not getting any calls. Below may be some of the reasons. Please remember there will always be a position that suits your profile, you have to just look for it, read the job eligibility and job description properly, and apply for it. Job openings on the company portal The below topic is regarding applications for job openings on the company portal. Below are some key points: Email Writing There is a common question among #freshers that we are emailing #cvs to many people but then to we are not getting any calls. Below are some reasons: Please note that A Proper email with a good #subjectline#body#cv is always appreciable. Telephonic/Virtual Interview Below the topic is a Telephonic Round of Interviews with #hr Many of us are waiting for getting calls from #recruiters, the question here is are we ready for it. Below are some key points regarding HR interview calls: Hopefully the above would help all. Interview in CDM Below are some basic topics that you need to be prepared for if you are looking to make your career in #clinicaldatamanagement. # Finally and Most Important-Basic Info of Organization you are looking for. -Establishment year -Number of Employees -CEO of Organization etc. -Mision and Vision of the Organization. Why do you want to work in Our Organization.-Why should we hire you.-Where do you see yourself after 5 years.-What are your career goals. All other basic Aptitude questions. Guidance to check the authenticity of job posts on LinkedIn Are all Job Openings posted for freshers Correct or its Fake? Always remember to review a person’s profile before commenting on his/her post or sending him/ her a connection request. Nowadays it’s been observed that people working in a particular organization are posting Job openings of some other organizations and posting just that ” DM me or Inbox me for details”. Think twice if a person is not in that Organisation He/ She can’t give you details and can’t refer you to that organisation. Such kinds of posts are just for making connections and misguiding people. But! If a person is posting some other organization’s openings and giving you a link to apply which is directing you to that organization’s page then no issues in such cases. Interview in PV This topic is #interview in #pharmacovigilance#pv Below are some basic topics that you need to be prepared if you are looking to make your career in #pharmacovigilance#pv Technical Round(Face-to-Face) Most Important Pharmacology in detail (Basic Info of All Classes of Drugs, MOA, Classification etc) The Basic Info of the Organization you are looking for. All other basic Aptitude questions. Which domain has a Good Career for Pharmacy or Life Science graduates post graduates? There are many questions in the minds of freshers regarding their Careers. Q1) Which field has better growth? Answer- Growth always depends on personal skills, knowledge, and quality of work. It is independent of the Field. You should always be the best in your field. Q2)Which field has a better package? Answer- The package depends on many factors. It also depends on Personal skills, Domain related experience, and knowledge. All domain has equal package offer. Q3) Which field has less workload etc.? Answer- There is workload everywhere and No workload anywhere. It’s totally dependent on the individual to balance and handle it. It is independent of any domain or company. Q4) Which field is more interesting? Answer- Choose a field in which you are good and whatever is your passion. Working in a domain in that you

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