Sr. Spclst, Drug Safety

Overview

The Senior Specialist, PV-PSM is responsible for management of all Company relationships, including business development partners, third-party vendors/suppliers, and emerging data sources. This may include negotiation and maintenance of PV agreements, and safety management plans (SMPs) with Company CRO partners and PV Plans.

Responsibilities

• Contribute to and provide subject matter expertise for PV templates for business development partners, third-party vendors/suppliers, and emerging data source deals to ensure compliance with global PV regulations.
• Under the direction of the Executive Director/Director/Associate Director, Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM), organize, conduct 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....