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AmerisourceBergen

Local Pharmacovigilance Specialist

1w

AmerisourceBergen

DE · Full-time · €60,000 – €85,000

About this role

At Cencora, team members are at the heart of creating healthier futures for people and animals. The Local Pharmacovigilance Specialist establishes and maintains the marketing authorisation holder’s local pharmacovigilance system. This role performs local Pharmacovigilance Operations to improve lives everywhere.

Main tasks include setting up the local pharmacovigilance system, local literature search, and ICSR management. Additional duties cover PV intelligence screening, PSMF maintenance, and local signal detection. The specialist also handles adaptation and submission of PSUR/RMP and implementation of risk minimization measures.

Close cooperation occurs with the global PV system, local departments, and the deputy who assumes responsibility during absences. Issue, review, and maintain pharmacovigilance procedures aligned with client practices. Participate in audits, inspections, meetings, and provide monthly PV reports.

Ensure PV training for affiliate employees, service providers, and third parties. Details on delegated local PV operations follow project-specific working practices. Join to make a difference at the center of health with an innovative company.

Requirements

  • Knowledge of local pharmacovigilance regulations and requirements
  • Experience in establishing local PV systems
  • Familiarity with ICSR processing and management
  • Understanding of PSMF maintenance and updates
  • Proficiency in signal detection and risk minimization
  • Ability to perform literature screening and PV intelligence
  • Experience with PSUR/RMP adaptation and submission

Responsibilities

  • Set up and manage the local pharmacovigilance system
  • Perform local literature search
  • Manage local ICSR
  • Conduct PV intelligence screening
  • Maintain local PSMF
  • Set up local organized data collection
  • Manage local PVA
  • Adapt and submit local PSUR/RMP

Benefits

  • Full-time position
  • Benefit offerings aligned to local market practice
  • Eligibility and effective dates may vary by country
  • Equal employment opportunity without regard to protected classes