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.

• US PV Implementation

- 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