Drug Safety Physician

Key Responsibilities-

• Acquiring comprehensive knowledge of the product portfolio and safety profiles for products across therapeutic areas.
• Perform analysis and medical assessment of the available information such as case reports and ICSRs.
• Triaging cases and determining seriousness and relatedness for assigned products.
• Perform medical review and assessment of ICSRs/safety information obtained from various sources (clinical trials/post-authorization).
• Reviewing appropriate selection of adverse events from source documents, assigning appropriate MedDRA code and drafting/reviewing case narratives.
• Determining reportability of cases obtained from various sources.
• Ensure effective functioning of assigned project in compliance with client agreements and applicable regulations and guidelines.
• Management of quality, compliance, and documentation across assigned projects.
• Have ownership of assigned projects and tasks and ensure adherence to timelines and quality.
• Manage and monitor the workload of department/function and alert the functional head/ designate in the event of concerns or issues regarding personnel management that may affect the quality and functioning of the work.
• Line management for assigned personnel.
• Continuously working with internal and external stakeholders to ensure compliance with agreements, applicable regulations, and guidance.
• Train and mentor personnel, as needed.
• Identify new training and development requirements relevant to the function.
• Respond to/represent department/function during audits and inspections.
• As assigned, author and review SOPs and other documents relevant for department/ function.
• Other responsibilities as assigned by the management.

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