Consumer Safety Manager, Consumer Safety Regions Europe and MEA
Core
Regional Pharmacovigilance (PV) point of contact managing day-to-day vigilance activities for marketed and developing products across EMEA markets.
Role type
Senior IC Pharmacovigilance Manager
Builds
Safety processes and compliance for consumer health products
Domain
Consumer health / Pharmaceuticals
Required skills
Pharmacovigilance procedures, Global regulatory compliance, Quality Control, Contractual documentation, Health authority submissions, Safety documentation translation, Local product list management, Literature search, PSMF maintenance
Preferred skills
Pharmacovigilance audits, EAEU markets experience
Technologies
Pharmacovigilance systems, Health authority submission portals
Responsibilities
Manage day-to-day vigilance activities for marketed and developing products; Ensure compliance with local, regional, and global pharmacovigilance requirements; Monitor local vigilance regulations and implement updates; Perform Quality Control activities including in-stream checks; Deliver Pharmacovigilance training to local departments and partners; Negotiate Safety Data Exchange Agreements (SDEAs); Support third-party pharmacovigilance due diligence; Manage DHCPL and DIL submissions to local Health Authorities; Maintain the local Pharmacovigilance System Master File (PSMF).
