Senior Director / Executive Director Medical Writing

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

Senior Director / Executive Director Medical Writing

Full-time

Department: Medical Writing

Medicine moves forward here. So will you.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

The Senior Director / Executive Director Medical Writing is a senior management position, member of the Senior Leadership Team; Acts as Head of PV Medical Writing Group and has primary responsibility to ensure the contracted PV activities are appropriately performed in line with company policies/procedures and in compliance with global regulations.

Responsibilities

• 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.

The preferred candidate will have:

• 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.