Sr. Spclst, Drug Safety

Job Description

Key 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), 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.
• Leads due diligence, capability assessments, and compliance review of partners and third-party vendors/suppliers.
• Maintains PV global standards for relevant activities to ensure compliance and quality of PV requirements.
• Develops and maintains the necessary processes to ensure high quality indivi...