Senior Director / Executive Director Medical Writing

About the role

PrimeVigilance is seeking a senior leader to head its Pharmacovigilance (PV) Medical Writing group. As a member of the Senior Leadership Team, you will ensure that all contracted PV activities are performed to the highest quality, compliance, and regulatory standards while supporting global patient‑safety initiatives.

Key responsibilities

• Lead the PV Medical Writing function, delivering high‑quality, compliant, and timely deliverables.
• Manage and develop a high‑performing PV Medical Writing team, fostering engagement and professional growth.
• Drive quality, compliance, inspection readiness, and continuous‑improvement initiatives, overseeing SOPs, KPIs, audits, and regulatory inspections.
• Provide strategic medical‑writing expertise to clients, internal stakeholders, and project teams.
• Support business‑development activities, including proposals, bid defenses, and client engagements.
• Oversee departmental resources, budgets, and operational performance.
• Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports, and other key pharmacovigilance deliverables.
• Build and maintain strong client relationships, ensuring exceptional service and trusted partnerships.
• Represent PrimeVigilance externally through industry engagement, publications, presentations, and professional development activities.

Required profile

• Extensive experience in pharmacovigilance and PV medical writing, including leadership of high‑performing teams.
• Deep knowledge of global pharmacovigilance regulations and expertise in authoring and reviewing aggregate safety reports and PV procedures.
• Proven track record supporting regulatory compliance, inspections, and pharmacovigilance system oversight (e.g., QPPV or Deputy QPPV responsibilities).
• Strong business‑development acumen and ability to engage with senior clients.
• Excellent communication and stakeholder‑management skills.

Required skills

• Pharmacovigilance expertise
• Medical writing
• Regulatory compliance
• Risk Management Plan development
• Leadership and team development