Head of Pharmacovigilance & Regulatory Quality Assurance

About the role

The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system. You act as the independent quality authority, ensuring that PV processes across clinical safety, regulatory affairs, and medical affairs meet global regulations, ICH guidelines, and company standards.

Key responsibilities

• Define and execute a risk‑based audit strategy aligned with GVP Module IV, covering internal, external, affiliate and third‑party audits.
• Lead preparation, conduct and response for health‑authority inspections and third‑party audits.
• Oversee PV system health through deviation management, CAPA, change management and KPI reporting.
• Provide GVP, GCP, GDP and GCLP consultancy across functional areas, ensuring cross‑GxP alignment.
• Manage PV IT systems, SOP quality, vendor relationships and budget/resource allocation.
• Drive continuous improvement by monitoring global regulatory trends and implementing corrective initiatives.

Required profile

• Extensive experience in pharmacovigilance, regulatory affairs and quality assurance at a senior leadership level.
• Proven ability to design and govern audit programmes and inspection readiness.
• Strong strategic mindset combined with hands‑on operational leadership.
• Excellent communication and stakeholder management skills with senior leadership.

Required skills

• Good Pharmacovigilance (GVP) knowledge.
• Clinical trial expertise (GCP).
• Distribution and product handling standards (GDP).
• Laboratory practice standards (GCLP).
• Experience with PV IT systems and CAPA processes.

What we offer

• Leadership role within a global R&D organization.
• Opportunity to shape worldwide PV quality strategy.
• Competitive remuneration package.