13 ago - Milano
PrimeVigilance
Job Description
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.
Qualifications
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 wit
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