Senior Specialist, Regulatory & PV Network
Core
Develop regulatory strategy and drive PV deliverables while serving as the Local Contact Person for Pharmacovigilance in a designated country.
Role type
Senior Specialist, Regulatory & PV Network (Local Contact Person)
Builds
Regulatory deliverables and pharmacovigilance safety data management
Domain
Pharmaceutical industry / Regulatory Affairs / Pharmacovigilance
Deliverable
client delivery
Required skills
Regulatory strategy development, Pharmacovigilance (PV) management, Project coordination, Risk identification, Vendor management, Training compliance, Audit support, SOP design, Performance tracking
Preferred skills
Experience with ICH GCP and GVP, Knowledge of national regulations, Proposal development support
Technologies
Regulatory intelligence database, 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 project setup activities, Provide strategic input and risk mitigation, Solve performance issues and delivery failures, Collect and maintain LCP records and reports, Monitor project budgets and hours, Support proposal development and budgeting, Provide training and mentoring to junior staff, Stay abreast of regulatory changes, Support audit/inspection preparation, Track KPIs and prepare monthly reports, Provide vendor performance feedback, Contribute to SOP design and company initiatives
