15 Aug
|
2028 Takeda Innovations India
|
Bengaluru
15 Aug
2028 Takeda Innovations India
Bengaluru
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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 ca
📌 Associate Director, Drug Safety Physician, Medical Review (Bengaluru)
🏢 2028 Takeda Innovations India
📍 Bengaluru