Senior Director – Medical Writing (Pharmacovigilance)

About the role

PrimeVigilance is seeking a Senior/Executive Director of Medical Writing to lead its Pharmacovigilance (PV) Medical Writing group. This senior management position sits on the Senior Leadership Team and is responsible for delivering high‑quality, compliant medical writing deliverables that support patient safety worldwide.

Key responsibilities

• Lead the PV Medical Writing function, ensuring timely, high‑quality outputs.
• Manage and develop a high‑performing medical writing team, fostering engagement and professional growth.
• Drive quality, compliance, inspection readiness, and continuous improvement across SOPs, KPIs, audits and regulatory inspections.
• Provide strategic medical writing expertise to clients, internal stakeholders and project teams.
• Support business development activities, including proposals and client engagements.
• Oversee departmental resources, budgets and operational performance.
• Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports and other PV deliverables.
• Build and maintain strong client relationships and represent the organization externally.

Required profile

• Master’s degree in life sciences or healthcare; PhD preferred.
• Extensive experience in pharmacovigilance and PV medical writing, including leadership of high‑performing teams.
• Deep knowledge of global PV regulations and experience authoring aggregate safety reports.
• Proven track record supporting regulatory compliance and inspections.

Required skills

• Pharmacovigilance regulations
• Medical writing for safety documents
• Risk Management Plans
• Aggregate safety report authoring