Senior Director, International Pharmacovigilance

Reporting to the Executive Director, Pharmacovigilance Operations, the Senior Director, International Pharmacovigilance is responsible for ensuring the effective management of pharmacovigilance activities in the EU, UK, and other non-US territories. This role involves strategic leadership, operational oversight, and ensuring compliance with global regulatory and business partner requirements. The Senior Director, International PV will lead the development and implementation of safety strategies and processes to support the safety of patients primarily through vendors.

This role is fully remote UK based. Travel to US headquarters or to international meetings may be required at the discretion of management.

Reporting to the Executive Director, Pharmacovigilance Operations, the Senior Director, International Pharmacovigilance is responsible for ensuring the effective management of pharmacovigilance activities in the EU, UK, and other non-US territories. This role involves strategic leadership, operational oversight, and ensuring compliance with global regulatory and business partner requirements. The Senior Director, International PV will lead the development and implementation of safety strategies and processes to support the safety of patients primarily through vendors.

This role is fully remote UK based. Travel to US headquarters or to international meetings may be required at the discretion of management.

Responsibilities (including, but not limited to):

• Providing oversight of international vendors and activities to ensure compliant safety reporting and management.
• Leading the strategic design, implementation, and operational execution of PV systems in the international (ex-US) markets
• Driving PV excellence in the international region via strong cross-functional collaborations (e.g., Medical, Commercial, Quality, Regulatory, Clinical)
• Overseeing local PV activities performed by national contact persons and QPPVs
• Acting as national contact person and/or QPPV in relevant territories, as needed
• Partnering with PV functions to advise on local aspects of case management (ICSR handling), risk management (RMPs and additional risk minimization measures), safety issues, aggregate report preparation, and SOPs.
• Scaling the international PV infrastructure, including outsourced services and internal resources, to support geographic expansion, regional clinical trials, and commercial product launches
• Overseeing compliant functioning of local activities in alignment with EU, UK, international, and local regulations and guidances
• Actively participating in the planning and conduct of audits and inspections
• Ensuring continuous maintenance of the PV System Master File

Qualifications:

• Advanced degree in a scientific discipline (e.g., PharmD, MD, PhD) preferred with 15+ years of experience in pharmacovigilance, with at least 5 years in a leadership role
• Demonstrated knowledge of relevant FDA, EMA, International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing both Safety reporting and processing for clinical trial environments
• Knowledge of MedDRA and WHO Drug Dictionary terminology and its application as well as experience with common safety database systems (Argus/ArisG/Veeva Safety)
• Development and review of SOPs and Work Instructions
• Vendor Management oversight responsibilities required. Experience with setting up a post-marketing PV vendor and global safety database preferred
• Excellent organizational skills and demonstrated ability to navigate in a fast-paced environment with changing priorities
• Excellent verbal and written communication skills including the ability to present to both internal and external partners
• Strong analytical and problem-solving skills
• Ability to work effectively in a fast-paced, dynamic environment
• High integrity and commitment to patient safety
• Collaborative and team-oriented approach
• Approximately 10-15% travel may be required
• The salary range for this position is commensurate with experience