Senior Director / Executive Director Medical Writing
ERGOMEDSarajevoFull TimeHealthcare
Remotely
pharmacovigilancemedical writingsopsregulatory inspectionsqppvaggregate safety reports
Job Description
📋 Description
- Lead the PV Medical Writing function ensuring high-quality, compliant, timely deliverables.
- Manage and develop the PV Medical Writing team for performance and growth.
- Drive quality, compliance, inspection readiness, and continuous improvement incl. SOPs, KPIs
- Provide strategic PV medical writing expertise to clients, stakeholders, and project teams.
- Support business development via proposals, bid defenses, and client engagements.
- Oversee resources, budgets, and operational performance for efficient service delivery.
🎯 Requirements
- Master’s degree in life sciences or healthcare; PhD preferred.
- Extensive pharmacovigilance and PV Medical Writing leadership experience.
- Deep knowledge of global pharmacovigilance regulations; expertise in aggregate safety reports and
- Experience with regulatory compliance, inspections, and PV system oversight; QPPV or Deputy QPPV
- Strong business acumen with proposals, client engagements, and bid defense experience.
- Excellent scientific, regulatory, and analytical abilities; ability to translate data into clear
🎁 Benefits
- Global pharmacovigilance environment with patient safety at the center.
- Collaborative, growth-oriented culture across multiple regions.
- Opportunity to engage with clients, industry peers, and professional development.
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