The Associate Director, Pharmacovigilance Partner Strategy & Management (PV-PSM) is responsible for PV management of all Company relationships, including business development partners, third-party vendors/suppliers, and emerging data sources. This role is responsible for independent negotiation and maintenance of business partner and vendor PV agreements and leadership of the General Clinical Safety & Pharmacovigilance (GCS&PV;) implementation activities for partner deals including but not limited to, acquisitions and divestiture deals. This role has accountability for the negotiation of safety management plans (SMPs) with Company CRO partners and the development/implementation of cross-divisional PV policy to enable enterprise-wide activities to be conducted in compliant ways for our emerging data sources such as patient support programs and social media.
Key Responsibilities
- Independently organizes, conducts and/or facilitates meetings with business development partners, CRO partners, third-party vendors/suppliers and internal stakeholders for the negotiation,
implementation, and maintenance of PV agreements, PV plans, and SMPs.
- Maintains, in collaboration with the Executive Director/Director/ Associate Director PV-PSM, the internal guidelines and procedures for creating, updating and retention of PV agreements, PV plans, and SMPs.
- Oversight of due diligence, capability assessments, and compliance review of partners and third-party vendors/suppliers.
- Responsible for ensuring the transfer of safety data to or from the partner is appropriate and complete. Assesses the requirements and liaises within the Pharmacovigilance Operations team to ensure appropriate data and/or algorithms are updated appropriately based on the requirements of the agreement.
- Collaborates with Executive Director/Director/Associate Director, PV-PSM to ensure training needs are assessed; creates and implements appropriate training as applicable in regard to new processe
📌 Assoc. Dir., Drug Safety (Bogotá)
🏢 Msd
📍 Bogotá
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