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Senior Director / Executive Director – Medical Writing
ERGOMEDSenior Director responsible for leading PV Medical Writing at PrimeVigilance. Ensuring compliance with regulations and quality deliverables while managing a high-performing team.
Core Competencies
Role fitCore Competencies
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Demonstrates extensive expertise in pharmacovigilance and PV Medical Writing, with a strong focus on regulatory compliance, quality assurance, and team leadership. Capable of translating complex clinical data into high-quality regulatory documents while fostering client relationships and driving operational performance.
Highest-signal resume keywords
Pharmacovigilance ExperiencePV Medical Writing LeadershipRegulatory Compliance ExpertiseClient Engagement SkillsAggregate Safety Report Authoring
ATS Keywords
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Hard Skills
PharmacovigilancePV Medical WritingRegulatory ComplianceAggregate Safety ReportsRisk Management PlansSOP DevelopmentKPI OversightAudit ManagementData AnalysisScientific Document Preparation
Soft Skills
Team ManagementClient Relationship BuildingStrategic ThinkingPerformance EngagementCommunication Skills
Industry Keywords
Global Pharmacovigilance RegulationsQPPV ResponsibilitiesBid Defense ActivitiesBusiness DevelopmentInspection Readiness
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Flexible work arrangements
- Professional development opportunities