Pharmacovigilance Regulatory Intelligence and Operations Strategy
Remote · United States
Job Summary
Pharmacovigilance Regulatory Intelligence and Operations Strategy consultant to provide global PV strategy and regulatory intelligence for drug-led and device-led combination products in clinical trials. Focus areas include interpreting country-specific PV regulations (OUS) for SK, Japan, Australia, and Canada; leading safety database setup and DSUR development; advising on PV operations start-up; and integrating drug and device PV requirements across cross-functional teams. Part-time, remote engagement with extensive PV regulatory expertise and multi-country clinical trial experience.
Required Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific/healthcare field required; advanced degree (e.g., MS, PharmD, PhD) preferred
- 10+ years of experience in Pharmacovigilance (PV) within the pharmaceutical, biotech, or combination products space
- Strong expertise in global PV regulations for combination products (drug-led and device-led)
- Experience supporting clinical trial PV activities (Phase I–III)
- Experience with PV regulatory intelligence and strategy development
- Safety database setup and configuration
- PV operations start-up and oversight
- Periodic safety reporting (e.g., DSURs)
- Regional or in-country PV expertise in South Korea, Japan, or Australia
- Location: Remote
- Consulting/ SME background
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