China PV Lead
Core
Oversees the Pharmacovigilance System for an affiliate, ensuring compliance with global and local regulations, managing adverse event reporting, risk management, and safety evidence generation.
Role type
Senior IC Pharmacovigilance Lead / National QPPV (backup)
Builds
PV system compliance, safety reporting, risk management plans, and business continuity for pharmaceutical products
Domain
Life Sciences / Pharmacovigilance
Required skills
Regulatory compliance, adverse event processing, risk management planning, audit management, safety data analysis, legislation monitoring, business continuity planning
Preferred skills
National QPPV designation, experience with outsourced partners, stakeholder management, safety advocacy
Technologies
PPS GPS, PSEQ, SDEA databases
Responsibilities
Ensure PV processes comply with global and local regulations; oversee adverse event intake, processing, and reporting to regulatory agencies; lead local risk management activities and Risk Management Plans; manage audits and inspections; establish business continuity and disaster recovery plans; act as key safety advisor for cross-functional partners.
Seniority
Senior, hands-on IC