Senior Specialist, Regulatory & PV Network
Core
Develop regulatory strategy and drive PV deliverables for pharmaceutical clients, acting as the local Pharmacovigilance contact person.
Role type
Senior Specialist, Regulatory & PV Network (Pharmacovigilance)
Builds
Regulatory deliverables, PV reports, and strategic plans for pharmaceutical clients
Domain
Pharmaceutical industry / Pharmacovigilance / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy development, Pharmacovigilance (PV) management, Project management, Risk identification and mitigation, Vendor management, Training compliance oversight, Audit/inspection support, SOP design, Performance tracking
Preferred skills
Experience with ICH GCP and GVP, Knowledge of national regulations, Proposal development support
Technologies
Regulatory intelligence databases, Project management plans, Operating procedures, Core documents
Responsibilities
Act as Local Contact Person for Pharmacovigilance, Lead medium/high complexity regulatory projects, Develop strategy and manage set up activities, Provide strategic input and risk mitigation, Solve performance issues, Maintain LCP records and training compliance, Monitor project budgets and hours, Support proposal development and budgeting, Prepare and review invoices, Mentor junior staff, Disseminate regulatory changes, Support audits/inspections, Track KPIs, Provide vendor feedback, Contribute to SOP design
Seniority
Senior, hands-on IC with leadership responsibilities
