Pharmacovigilance T05
Core
Acts as the Affiliate's main contact point for pharmacovigilance matters with National Regulatory Agencies and AbbVie Global Patient Safety, managing periodic safety reporting, audits, risk management, and safety monitoring for medicinal products.
Role type
Senior Pharmacovigilance Specialist (Affiliate PV)
Builds
Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), and local safety strategies for regulatory submissions.
Domain
Healthcare / Pharmaceutical Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Pharmacovigilance regulations, Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR), Audit and inspection management, Safety data monitoring, Regulatory agency liaison
Preferred skills
Launch readiness strategy, Cross-functional stakeholder management, Evidence generation for risk management
Technologies
PV systems, Regulatory submission platforms
Responsibilities
Partner with Regional PV Team to support Periodic and Aggregate Reports; Act as key contact for Affiliate PV audits and Regulatory Authority inspections; Coordinate receipt and distribution of Risk Management Plans (RMPs) and Core Implementation Strategy (CIS); Maintain overview of medicinal product safety profiles and monitor incoming local safety data; Ensure Affiliate PV System procedures align with corporate PV procedures and local regulations.
Seniority
Senior, hands-on IC