3 Medical Reviewing Jobs

The Content Solutions team at Indegene focuses on diverse projects throughout the product life cycle, covering regulatory, safety, medical affairs, and commercial solutions for clients. Leveraging clinical and scientific knowledge, the team addresses various business challenges to engage target audiences such as physicians and patients in different therapy areas. As a member of the team, you will have the opportunity to collaborate with healthcare clients on a variety of projects. Indegene is currently seeking a Scientific Writer and Reviewer to fulfill the role of a quality medical reviewer/technical reviewer for promotional, disease education, and training materials on behalf of a pharmaceutical client. Your responsibilities will include conducting procedural reviews to ensure compliance with MCA guidelines, verifying data accuracy, evaluating content based on references, and correctly interpreting information from sources. The role requires delivering and reviewing high-quality, comprehensive, and timely content. Key responsibilities also involve cross-checking scientific information with references for accuracy, ensuring alignment with approved product labeling, assessing adherence to MCA guidelines, validating reference quality and accuracy, maintaining consistency in reference citation style, verifying the presence of crucial information, defending content based on scientific evidence, and demonstrating a willingness to learn and write for various therapy areas and markets. In addition, you will liaise with client medical and other stakeholders to provide content clarifications, prioritize review assets as per requests, and adhere to agreed-upon timelines for review and submission. To qualify for this position, you should hold an advanced bioscience or pharmacy/medical qualification, possess excellent verbal and written communication skills, demonstrate a strong scientific acumen, and have 1-5 years of experience in the pharmaceutical industry. This experience should include content writing and review related to medical affairs/medical information, literature reviews, publications support, and promotional/non-promotional medical review. The job location for this position is in Bengaluru, Hyderabad, Pune, Mumbai & Delhi NCR on a hybrid work model.,

Job Responsibilities: (Medical Reviewing - PV) Performing the Case Analysis and Peer Review (Quality check) Perform medical review (including verifying the coding & labelling reviewing narratives causality statement medical aspect of follow-up request) validate follow-up request and perform medical assessment of the case for the Category I and II cases Prioritize workloads to ensure expedited cases are processed within defined timelines Responsible for the timely completion of individual cases and meeting the SLA for data entry and case analysis activity as per SOP. Approval and the locking of Category I cases Responsible for the timely reception of an individual case on a daily basis. Responsible for registration in e-logbook and for the duplicate search process. Ensure quality and timely creation and closure of PV query as per SOP. Ensure the filing of PV dossier and documents as per the SOP Contact Person : Sangeetha Tamil

Job Title: Medical Reviewer Employment Type: Full time Location: Bengaluru / Hyderabad /Remote Experience: 3 to 5 Years (MCI registration is must) About ClinChoice: ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance. Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc. Support triage of cases and determine seriousness and relatedness across products as assigned. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement activities such as implementation of quality control process. Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries. Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate. Maintain PV expertise, and understanding of international safety regulations and guidelines. Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines. Provide timely feedback to case processors on the errors/ discrepancies noted. Assist in training/mentoring of other case processing/medical review personnel as necessitated. Adapt to different client case processing conventions and multi-task as per business needs. Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement. Participate in organizational activities to meet objectives suitable for the role/area of expertise. Candidate Profile: Should be a MBBS/MD with 3- 5 years of experience as Medical Reviewer for all case scenarios. Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements. Training and mentoring skill (GVP concepts & medical aspects such as disease condition, product portfolio etc) Must have hands on experience with MS Office applications (Outlook, Excel, Word, Power Point etc)