Executive Director, Global PV Medical Writing

PrimeVigilance; Lisboa; Presencial; EUR 120 000 - 180 000; Tempo integral

Resumo da oferta

PrimeVigilance seeks a Senior Director / Executive Director Medical Writing to lead the PV Medical Writing group, ensuring high-quality, compliant, and timely deliverables across projects.

As part of the Senior Leadership Team, you will manage a high-performing team, oversee regulatory submissions, and drive strategy, growth, and client engagements while upholding patient safety as the core value.

Qualificações

• Masters degree or higher in life sciences/healthcare; PhD preferred.
• Extensive pharmacovigilance and PV Medical Writing experience including leadership.
• Deep knowledge of global pharmacovigilance regulations and PV procedures.
• Experience supporting regulatory compliance, inspections, and PV oversight.
• Strong business acumen with client engagements and bid defense experience.
• Excellent scientific, regulatory, and analytical capabilities.

Responsabilidades

• Lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables.
• Manage and develop the PV Medical Writing team, fostering performance, engagement, and growth.
• Drive quality, compliance, inspection readiness, and continuous improvement, incl. SOPs, KPIs, audits, and inspections.
• Provide strategic PV 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 to ensure efficient service delivery.
• Review regulatory safety responses and contribute to Risk Management Plans and aggregate reports.
• Build and maintain strong client relationships, ensuring exceptional service and trusted partnerships.
• Represent the organization externally through industry engagement, publications, presentations, and professional development.

Conhecimentos

PV Medical Writing leadership

Team management

Regulatory knowledge

Client engagement

Bid defense support

Formação académica

Master’s degree in life sciences or healthcare

PhD preferable

Descrição da oferta de emprego

PrimeVigilance seeks a Senior Director / Executive Director Medical Writing to lead the PV Medical Writing group, ensuring high-quality, compliant, and timely deliverables across projects.

As part of the Senior Leadership Team, you will manage a high-performing team, oversee regulatory submissions, and drive strategy, growth, and client engagements while upholding patient safety as the core value.