Manager (m/w/d) Pharmacovigilance
Core
Manage the global Pharmacovigilance (PV) system to ensure product safety monitoring and documentation compliance for pharmaceutical products.
Role type
Manager, Pharmacovigilance
Builds
Global PV system, safety documentation (PSURs, RMPs, PSMF), risk minimization measures, and training programs.
Domain
Pharmaceuticals / Regulatory Compliance
Required skills
Pharmacovigilance system development, scientific evaluation of adverse events, signal detection, risk minimization planning, audit preparation, SOP management, stakeholder coordination
Preferred skills
AI/ML tool adoption for literature search and signal detection, French language proficiency (via careerplan.io/jobs/1113083-manager-mwd-pharmacovigilance-at-denk-pharma-gmbh-co-kg)
Technologies
ARISg, Veeva Vault Safety
Responsibilities
Develop and optimize global PV systems and databases; create and maintain essential PV documents and SOPs; evaluate adverse event reports and manage signal detection; implement risk minimization measures; prepare for regulatory audits and inspections; conduct PV training for partners and employees; coordinate with internal departments and international distributors
Seniority
Manager, hands-on IC