Description:
Primary Responsibilities:
- Represents the Global Pharmacovigilance Team (GPV) in the negotiation, contractual management, and operational maintenance of Third-Party Pharmacovigilance Agreements (PVAs).
- In collaboration with Global Pharmacovigilance functional lines, drive relevant planning, execution, and governance of PVAs in partnership with PV Legal.
- Responsible for alignment with Business Development related to the overall delivery of quality licensing agreement deliverables and participation in due diligence efforts.
- Contributes to PVA process improvement initiatives.
- Independently assesses, writes, updates, maintains, and stores PVAs according to internal guidelines and Company policies and standards.
- Independently organizes, conducts and/or facilitates meetings with business partners in the negotiation of PVAs.
- Supports PVA and New Business Integration/Divestment process: Responsible for monitoring the Alliance contract and escalating as appropriate for contractual issues.
- PVA development - own end-to-end process of development, execution, maintenance, and termination (when applicable) of PVAs and associated deliverables. May include strategy setting, with input, as necessary, from line management.
- Sets tactical approaches and drive more effective operational plans for PVA negotiation and execution.
- Maintains the internal guidelines for creating, updating and retention of business partner related PVAs.
- Responsible for ensuring that the transfer of legacy data to or from the business partner is appropriate and complete. Assesses the requirements and liaises with Pharmacovigilance Operations team to ensure appropriate data and/or algorithms are updated appropriately based on the requirements of the agreement.
- Management of applicable PVA related vendor team(s).
- Identifies and prioritizes workload to maintain compliance with departmental and regulatory reporting requirements.
Education Minimum Requirements:
- Required: Bachelor's degree
- Preferred: Master's degree
Required Experience and Skills:
- A minimum of seven years pharmaceutical experience or relevant professional experience.
- At least 2 years managing individual contributors Experience with Veeva system.