Provide strategic scientific and operational PV support for clinical development products, including those transitioning from early to late-phase development
Job Summary
Provide strategic scientific and operational PV support for clinical development products, including those transitioning from early to late-phase development.
Partner closely with Clinical, Regulatory, Medical, Biostats, and external partners to ensure proactive signal detection and safety risk management in alignment with global regulatory expectations.
Help shape the growth of the safety function, including evaluating tools, technologies, and vendors to support future scalability and contributing to team hiring, mentoring, and onboarding.
Matching Summary
Provide strategic scientific and operational PV support for clinical development products, including those transitioning from early to late-phase development.
Skills & Requirements
Must-have
Pharmacovigilance (PV) team
Safety data signal management
PV organization and process development
Aggregate data review and signal detection
Individual case safety report assessments
Reference Safety Information (RSI) development
Global safety regulations and ICH guidelines
Nice-to-have
Dynamic, fast-paced environment
Proactive signal detection and risk management
Inspection readiness and vendor management
Mentoring and team development
Player-coach approach
Key Requirements
Advanced clinical degree (MD, DO, or equivalent)
Minimum 8 years of experience in drug safety/pharmacovigilance
At least 4+ years in safety science roles in clinical development
Experience in biotech or small-to-mid-size pharma environment
Experience with safety databases (e.g., Argus, VeevaSafety)
Experience with MedDRA coding, Points to Consider, AoSE and SMQs
Prior involvement in NDA/BLA/MAA submissions or regulatory agency interactions preferred