Senior Associate, Medical Review Physician

<p><strong>Primary Responsibilities:</strong></p> <ul> <li>Awareness and understanding of relevant GVP modules.</li> <li>Perform medical review of non-serious &amp; serious ICSRs with emphasis on seriousness, expectedness, causality &amp; narrative etc. without missing on quality &amp; compliance.</li> <li>Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.</li> <li>Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc.</li> <li>Support triage of cases and determine seriousness and relatedness across products as assigned.</li> <li>Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.</li> <li>Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.</li> <li>Involve in process improvement activities such as implementation of quality control process.</li> <li>Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.</li> <li>Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.</li> <li>Maintain PV expertise and understanding of international safety regulations and guidelines.</li> <li>Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.</li> <li>Provide timely feedback to case processors on the errors/ discrepancies noted.</li> <li>Assist in training/mentoring of other case processing/medical review personnel as necessitated.</li> <li>Adapt to different client case processing conventions and multi-task as per business needs.</li> <li>Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.</li> <li>Participate in organizational activities to meet objectives suitable for the role/area of expertise.</li> </ul> <p><strong>Candidate Profile:</strong></p> <ul> <li>Medical Physician with at least 2 years of experience as Medical Reviewer for ICSRs.</li> <li>Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.</li> <li>Training and mentoring skills (GVP concepts &amp; medical aspects such as disease condition, product portfolio etc).</li> <li>Must have hands-on experience with MS Office applications (Outlook, Excel, Word, Power Point etc).</li> </ul>