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Job Description:

The Associate Director, Medical Review supports Global Pharmacovigilance with an emphasis on overseeing medical assessment of individual case safety reports from investigational and marketed product across all therapeutic areas. They are responsible for performing high quality medical assessment of individual case safety reports in the Global Safety Database to ensure compliance with domestic and international regulations, and ensure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to queries

Primary duties and responsibilities of the role include the following





Perform and conduct oversight of global medical review of individual case safety reports for Takeda investigational and marketed products from all sources, including but not limited to the following
seriousness criteria confirmation and expectedness/listedness assessment
review of the reporter’s causality and company causality assessment
event confirmation and coding as per convention,
analysis of similar events as required,
provide sound rationale in Company Comment regarding causality,
ensure due diligence in adequate follow-up, and timeliness of expedited reports
Collaborate with other PSPV personnel from other functions (AE processors, safety scientists and Global Safety Leads) in evaluating the safety profile of Takeda products.
Establish with alliance partners harmonization and industry standard medical review and case assessment standards
Ensure effective communication with both internal and external stakeholders on individual case safety assessment

📌 Associate Director, Drug Safety Physician, Medical Review (Bengaluru)
🏢 Takeda
📍 Bengaluru