Senior Director, PV Medical Writing & Strategy

PrimeVigilance; Madrid; Presencial; EUR 140.000 - 180.000; Jornada completa

Descripción de la vacante

PrimeVigilance seeks a Senior Director / Executive Director Medical Writing to lead the PV Medical Writing group and ensure contracted activities are performed in line with company policies and global regulations.

You will provide strategic leadership, manage a high-performing team, drive QA, inspection readiness, and support business development across global pharmacovigilance projects.

Formación

• Master’s degree in life sciences or healthcare; PhD preferable.
• Extensive pharmacovigilance and PV medical writing leadership experience.
• Deep knowledge of global pharmacovigilance regulations and reports.
• Experience with regulatory compliance, inspections, and PV system oversight including QPPV responsibilities.
• Strong business acumen with experience supporting proposals, client engagements, and bid defenses.
• 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 professional growth.
• Drive quality, compliance, inspection readiness, and continuous improvement initiatives, including SOPs, KPIs, audits, and regulatory inspections.
• Provide strategic PV medical writing expertise and subject matter leadership 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, aggregate reports, and other key pharmacovigilance deliverables.
• Build and maintain strong client relationships, ensuring exceptional service and trusted partnerships.
• Represent the organization externally through industry engagement, publications, presentations, and professional development activities.

Conocimientos

Leadership

PV Medical Writing

Regulatory knowledge

Client engagement

Proposal support

Educación

Master’s degree in life sciences or healthcare

PhD preferable

Descripción del empleo

PrimeVigilance seeks a Senior Director / Executive Director Medical Writing to lead the PV Medical Writing group and ensure contracted activities are performed in line with company policies and global regulations.

You will provide strategic leadership, manage a high-performing team, drive QA, inspection readiness, and support business development across global pharmacovigilance projects.