Pharmacovigilance Regulatory Intelligence and Operations Strategy

Pharmacovigilance Regulatory Intelligence And Operations Strategy Consultant We are seeking an experienced Pharmacovigilance (PV) Regulatory Intelligence and Operations Strategy Consultant to support global clinical trials for drug-led combination products (drug/device). This role will provide strategic and operational PV expertise across multiple geographies, ensuring compliance with country-specific regulations and enabling successful clinical trial execution. This engagement is part-time and ad hoc, supporting a growing need for global PV strategy, regulatory intelligence, and operational setup. Responsibilities • Provide PV regulatory intelligence and strategy for global combination product clinical trials, with a focus on drug-led drug/device products • Interpret and apply country-specific PV regulations (OUS) for: • South Korea • Japan • Australia • Canada • (Future scope: multiple European countries) • Support safety database strategy and setup, ensuring alignment with regulatory requirements for combination products in clinical phases • Lead or advise on PV operations setup and start-up activities for global clinical trials • Provide expertise in adverse event and device event reporting, including: • Adverse Drug Events (ADEs) • Serious Adverse Events (SAEs) • Serious Adverse Device Effects (SADEs / USADEs) • Medical device deficiencies • Support development and execution of periodic safety reports (e.g., DSURs and other applicable reports) for combination products across clinical phases • Advise on integration of drug and device PV requirements, including differences between drug-led and device-led combination product regulations • Collaborate with cross-functional stakeholders (Clinical, Regulatory, Quality, and Safety teams) • Provide strategic guidance and gap assessments for global PV compliance and readiness 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, including both: • Drug-led combination products • Device-led combination products • Demonstrated experience supporting clinical trial PV activities (Phase I–III) • Deep knowledge of OUS PV regulatory frameworks, especially in: • South Korea • Japan • Australia • Canada • 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) • Strong understanding of adverse event reporting requirements across global markets • Experience with single-use on-body injectors for subcutaneous administration • Regional or in-country PV expertise in South Korea, Japan, or Australia • Experience supporting multi-country or global clinical trials • Background working as a consultant or SME in an advisory capacity Location • Remote Employment Type • Part-time • Consulting