Job Description
Director / (Head or Lead) of Pharmacovigilance (US) Location : United States
About the Role We are seeking a highly experienced Director / Head of Pharmacovigilance (US) to establish and lead our US PV presence within a globally integrated, EU-headquartered pharmacovigilance organization.
This role is critical in ensuring that US regulatory requirements are effectively implemented within a globally led PV system, without creating a standalone or siloed US function. The successful candidate will act as a key bridge between the US and EU headquarters, ensuring alignment, consistency, and compliance across regions.
During the initial 12-24 months, this role requires a hands-on leader who can both build the function and contribute operationally, in close collaboration with the Global PV/QPPV Office.
Key Responsibilities • Global Integration & Governance
- Operate within a globally centralized PV framework led from EU headquarters, ensuring US alignment with global strategy, processes, and governance.
- Act as the primary US interface to global PV leadership and QPPV Office, promoting a "one PV organization" mindset.
- Ensure US requirements are integrated into global activities without duplication or regional divergence.
- Establish and maintain a compliant, inspection-ready US PV set-up, aligned with global systems and adapted to FDA requirements.
- Ensure appropriate execution of US-specific PV obligations, acting as the accountable local representative within the global model.
- Serve as the primary PV contact for FDA, supporting inspections and regulatory interactions.
- Operational Contribution (Globally Led Model)
- Work within a structure where core PV activities (case processing, signal detection, aggregate reporting) are led by EU/global teams.
- Maintain strong oversight and awareness of global activities, ensuring US regulatory nuances and timelines are appropriately addressed.
- Contribute to global processes through US regulatory expertise, including input into case handling, reporting requirements, and signal evaluation.
- Execute locally required PV tasks (e.g., US-specific submissions, local regulatory commitments, REMS/RMP components where applicable, local vendor management and oversight).
- Hands-On Leadership (Build Phase)
- Operate with a hands-on approach during the first 12-24 months, directly supporting key PV activities as needed.
- Collaborate closely with EU/global teams to implement processes, address gaps, and ensure operational continuity.
- Gradually transition toward a strategic oversight role as the US function and team mature.
- Team Building & Cross-Functional Leadership
- Build and develop a lean, high-performing US PV team, fully integrated into the global organization.
- Partner with stakeholders across Clinical, Regulatory, Medical Affairs, and Quality in both US and EU.
- Actively contribute to global PV initiatives and continuous improvement efforts.
Qualifications - Advanced degree in Life Sciences, Pharmacy, or Medicine (PharmD/MD/PhD preferred)
- 2-15+ years in Pharmacovigilance, including senior leadership experience
- Strong expertise in FDA PV requirements, with solid knowledge of EMA/ICH
- Proven experience in global/matrix environments, with close collaboration with EU headquarters
- Demonstrated ability to build or scale PV capabilities in biotech settings
- Experience with regulatory inspections and authority interactions (FDA)
What Sets You Apart - Strong global mindset-you prioritize alignment over regional autonomy
- Ability to lead hands-on while building for scale
- Skilled in influencing across regions and functions
- Comfortable operating within centrally governed, globally distributed models
Job Tags
Work at office, Local area