Responsibilities
- Oversee case processing activities, including intake, triage, medical review support, and expedited reporting
- Ensure compliance with global safety reporting requirements (FDA, EMA, ICH guidelines)
- Manage relationships with PV vendors/CROs, ensuring service quality, timeliness, and data integrity
- Support maintenance of safety databases and related systems
- Lead preparation of DSURs, PSURs/PBRERs, and IND safety reports
- Support safety sections of regulatory submissions and responses to health authority queries
- Contribute to development and maintenance of SOPs and Pharmacovigilance System Master File (PSMF)
Requirements
- Advanced degree (PharmD, PhD, MD, or MS) or health‑related degree/certification (PA, RN, NP)
- At least 10 years of pharmacovigilance experience in biotech or pharmaceutical industry
- Experience supporting clinical‑stage programs
- Working knowledge of global pharmacovigilance regulations (FDA, EMA, ICH)
- Familiarity with aggregate reporting and signal detection processes
- Experience in oncology, cell therapy, or gene therapy preferred
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