Manager, Regulatory Affairs & Pharmacovigilance, Central EPM
Core
Oversee regulatory and pharmacovigilance operations for the Central Cluster (Romania, Moldova, Hungary, Czech Republic, Slovakia) to ensure compliance with local and international requirements.
Role type
Manager, Regulatory Affairs & Pharmacovigilance
Builds
Regulatory strategies, submission documents, safety reports, and operational systems for drug products.
Domain
Pharmaceuticals / Regulatory Compliance / Pharmacovigilance
Required skills
Regulatory strategy development, pharmacovigilance system management, adverse event reporting, vendor qualification, SOP creation, audit management, stakeholder liaison, budget management, risk minimization planning.
Preferred skills
Knowledge of local regulatory authorities, experience with Veeva Safety Vault, ability to manage cross-functional teams, translation oversight.
Technologies
Veeva Safety Vault
Responsibilities
Act as primary contact for national Medicines Agencies; develop and implement regulatory strategic plans; manage adverse event collection, review, and reporting; oversee vendor qualification and audits; create and update RA/PV SOPs; ensure compliance with GVP/GxP standards; manage safety mailboxes and aggregate reports. (via careerplan.io/jobs/67-00A-23-A62-manager-regulatory-affairs-pharmacovigilance-central-epm)
Seniority
Manager, hands-on IC