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Senior Manager, Drug Safety Clinical And Post - Marketing Operations
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- The Senior Manager, Drug Safety Clinical and Post-marketing Operations will lead the management of the pharmacovigilance (PV) vendor on a day to say basis, ensuring that pharmacovigilance and risk management activities are managed in compliance with local regulations and company policies/procedures at a local, regional, and global level and in accordance with any agreements with business partners.
- This role with report directly to the Senior Manager, Drug Safety Operations & Compliance and the Drug Safety department and provide process-related expertise, support, and direction for pre- and post-marketing safety related activities.
- Back-up to the Senior Manager, Drug Safety Operations & Compliance.
- Ensure clinical trial and post-marketing case reporting processes are efficient and compliant with regulatory reporting requirements & reporting requirements detailed in the applicable plan/ agreement (i.e. safety management plans (SMP) / PV agreements).
- Provides guidance to PV vendor on technical aspects of clinical trials and post-marketing activities/commitments, including configuration of the Global Safety Database and relevant reporting rules, as applicable.
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