Senior Director / Executive Director Medical Writing
ERGOMEDRemotely
pharmacovigilancemedical writingregulatoryauditssafety reportingqppvpv procedures
Job Description
📋 Description
- Lead the PV Medical Writing function and ensure high-quality, compliant, and timely deliverables.
- Manage and develop the PV Medical Writing team, fostering performance and professional growth.
- Drive quality, compliance, inspection readiness, and continuous improvement (SOPs, KPIs, audits
- Provide strategic PV medical writing expertise to clients, internal stakeholders, and project teams.
- Support business development activities including 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 preferable
- Extensive pharmacovigilance and PV Medical Writing experience with leadership
- Deep knowledge of global pharmacovigilance regulations with expertise in safety reports and PV
- Experience supporting regulatory compliance, inspections, and PV system oversight (QPPV or Deputy
- Strong business acumen with experience in proposals, client engagements, and bid defense
- Excellent scientific, regulatory, and analytical capabilities to translate data into regulatory
🎁 Benefits
- Join a global pharmacovigilance specialist focused on patient safety
- Collaborative culture across Europe, North America, South America, Asia and Australia
- Values-based environment emphasizing quality, integrity, drive, agility, belonging, and
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