Medical Affairs Manager - Pharmakovigilanz (m/w/d)
Core
Provide drug information for Hameln products in response to medical/pharmaceutical inquiries from the German/Austrian professional community and support the creation and review of aggregated safety reports (PSURs, PBRERs).
Role type
Medical Affairs/Pharmakovigilanz Manager
Builds
Aggregated safety reports (PSURs, PBRERs), drug information responses, and supports lifecycle management and licensing projects
Domain
Pharmaceuticals, Regulatory Affairs, Safety Monitoring
Required skills
Pharmaceutical/medical expertise, knowledge of injectable drugs, understanding of current and evolving pharmaceutical legislation, document management system experience, MS Office proficiency
Preferred skills
Experience with injectable drugs, knowledge of AMG § 63a (EU-QPPV qualification path)
Technologies
docuBridge, MS Office
Responsibilities
Answer medical/pharmaceutical inquiries for German/Austrian professionals, support creation and review of PSURs/PBRERs, assist in lifecycle management and licensing projects, handle adverse drug reaction reports and risk minimization measures, communicate with authorities regarding recalls or suspected counterfeit cases, evaluate quality defects for drug safety relevance, review marketing materials for medical accuracy
Seniority
Mid-level, hands-on IC