Manager, Regulatory Affairs & Pharmacovigilance, Central EPM
Core
Oversee regulatory and pharmacovigilance operations for Romania, Moldova, Hungary, Czech Republic, and Slovakia to ensure compliance with local and international requirements.
Role type
Manager, Regulatory Affairs & Pharmacovigilance
Builds
Regulatory strategies, submission documents, safety reports, and compliance systems for Medison products and partner products.
Domain
Pharmaceuticals / Regulatory Affairs / Pharmacovigilance
Required skills
Regulatory strategy development, liaison with national agencies, pharmacovigilance system management, adverse event reporting, SOP creation, vendor qualification, audit management, risk management plan implementation, translation oversight.
Preferred skills
Experience with Veeva Safety Vault, knowledge of GVP/GxP guidelines, ability to manage cross-functional teams, experience with MAH (Marketing Authorization Holder) responsibilities.
Technologies
Veeva Safety Vault
Responsibilities
Act as primary contact for national Medicines Agencies; manage local pharmacovigilance activities including AE collection and reporting; develop and implement regulatory strategic plans; oversee RA and PV vendors; prepare submission documents for drug codes; ensure compliance with Medison SOPs and partner procedures; manage safety mailboxes and aggregate reports; conduct or support regulatory and GVP audits; create and update RA/PV SOPs and training programs. (via careerplan.io/jobs/67-00A-23-A62-manager-regulatory-affairs-pharmacovigilance-central-epm-at-medison-pharma)
Seniority
Manager, hands-on IC