Senior Associate, Medical Review Physician

Job description

**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:** - Medical Physician with at least 2 years of experience as Medical Reviewer for ICSRs. - Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements. - Training and mentoring skills (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).