Associate Director, Pharmacovigilance
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full-time
Posted on:
Location Type: Remote
Location: Pennsylvania • United States
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Job Level
About the role
- Support the daily management and execution of pharmacovigilance operations.
- Ensure compliance with regulatory requirements, PV agreements, and internal SOPs.
- Contribute to the oversight of drug safety activities and cross-functional safety initiatives.
- Assist in developing, implementing, and maintaining PV processes, SOPs, and quality standards.
- Support oversight of adverse event (AE) collection, review, and reporting.
- Participate in the medical review process for ICSRs, as appropriate.
- Support preparation of periodic safety reports (PSURs, DSURs) and benefit-risk assessments.
Requirements
- Advanced degree in medicine, pharmacy, nursing, or related scientific field preferred.
- Minimum of 6–8 years of experience in drug safety operations (case management, signal detection, risk management, regulatory reporting).
- Experience working with external vendors/CROs required.
- Experience in cardiovascular disease and post‑marketing PV activities preferred.
- Strong communication, collaboration, and organizational skills.
- Proficiency with safety database systems and PV software tools.
Benefits
- health insurance
- dental and vision coverage
- term life and disability coverage
- retirement plans
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilance operationsdrug safety activitiesadverse event collectionmedical review processperiodic safety reportscase managementsignal detectionrisk managementregulatory reportingpost-marketing PV activities
Soft Skills
communicationcollaborationorganizational skills
Certifications
advanced degree in medicineadvanced degree in pharmacyadvanced degree in nursing