Global PV Medical Writing Director

Ergomed Group; Lisboa; Presencial; EUR 120 000 - 180 000; Tempo integral

Resumo da oferta

PrimeVigilance in Lisbon is seeking a Senior Director / Executive Director Medical Writing to lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables.

As a senior member of the leadership team, you will oversee the PV Medical Writing group, drive quality, inspection readiness, and contribute to strategic client engagements and business development. This role offers global reach and a real sense of purpose.

Qualificações

• Extensive pharmacovigilance and PV Medical Writing experience, including leadership and people management of high-performing teams.
• Deep knowledge of global pharmacovigilance regulations, with expertise in authoring and reviewing aggregate safety reports and PV procedures.
• Proven experience supporting regulatory compliance, inspections, and pharmacovigilance system oversight, including QPPV or Deputy QPPV responsibilities.
• Strong business acumen with experience supporting proposals, client engagements, and bid defense activities.
• Excellent scientific, regulatory, and analytical capabilities, including translating complex clinical and safety data into clear, high-quality regulatory and scientific documents.

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 oversight of 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.

Conhecimentos

PV Medical Writing Leadership

Pharmacovigilance

Regulatory Reporting

Team Management

Client Engagement

Proposal Support

Descrição da oferta de emprego

PrimeVigilance in Lisbon is seeking a Senior Director / Executive Director Medical Writing to lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables.

As a senior member of the leadership team, you will oversee the PV Medical Writing group, drive quality, inspection readiness, and contribute to strategic client engagements and business development. This role offers global reach and a real sense of purpose.