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 When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
Quality: we hold ourselves to the standard patients deserve.
Integrity and trust: we do the right thing, especially when it is hard.
Drive and passion: we care about the outcome, because someone is waiting on it.
Agility and responsiveness: we move quickly, because patients cannot wait.
Belonging: everyone is welcome, and every voice counts.
Collaborative partnerships: we go further by going together. We look forward to welcoming your application.
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.
Ergomed is a specialized Contract Research Organization (CRO) operating through its PrimeVigilance division, which was established in 2008 and has achieved consistent global organic growth. The company provides comprehensive pharmacovigilance services including Medical Information, Regulatory Affairs, and Quality Assurance to pharmaceutical and biotechnology clients, covering all therapy areas and medical devices. Ergomed specializes in Oncology and Rare Disease clinical trials, with a focus on both early-phase and contracted pharmacovigilance activities. The company maintains a global presence with staff based across Europe, North America, and Asia, serving as one of the leaders in pharmacovigilance and clinical research services.
