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Manager, Affiliate PV Coordinator (m/f/d)

Hybrid
  • Hessen, Deutschland
Global Pharmacovigilance

Jobbeschreibung

  • This position is responsible for the maintenance and creation of departmental procedures including, but not limited to, Standard Operating Procedures (SOPs, as applicable)
  • This position also ensures that the EU affiliates are supported in the performance of pharmacovigilance activities according to SOPs and the regulatory and global requirements.
  • Coordinates safety-related communication between Local Safety Managers (LSMs), Local Contacts for Pharmacovigilance (LPPVs), Local PV Contact Persons (LPVCPs) and global or regional functions. Ensures management of the regional network of LPPVs/LPVCPs, including External Service Provider (ESP) contracts and correctness of related invoices.
  • Distributes tasks and responsibilities, oversees performance management, and training compliance of individual team members and personnel development.
  • Additional Job Description
    • Provides support for APVC activities
    • Addresses or coordinates PV-related issues with relevant global or local functions for a resolution
    • Organizes and supports periodic or ad hoc trainings or meetings with local and global PV
    • Supports global PV teams to implement new procedures, systems and requirements
    • Supports establishment of a compliant PV system in the affiliates
    • Monitors and supports local PV system improvement in the affiliates
    • Oversees applicable written PV procedures in the affiliates
    • Reviews and provides PV-relevant inputs for GSOPs from the LSMs/ LPPV/LPVCP perspective
    • Acts as a subject matter expert for APVC related subjects as applicable, in PV related regulatory inspections or quality assurance / corporate compliance audits and supports with deviations and CAPAs, as required
    • Ensures work is properly documented and filed
    • Supports, reviews and QC’s assigned PSMF Annexes, as applicable
    • Acts as a liaison internally and with external pharmacovigilance service providers and business partners on drug safety and PV issues, as assigned by PV management

Stellenanforderungen

  • Education in healthcare of life sciences (e.g. biological sciences, pharmacy, nursing, physician assistants, nurse practitioners) preferably at bachelor level (or comparable local degree) or higher
  • Minimum 3 years’ experience in PV or PV-related area in the pharmaceutical industry or Health Authority
  • Speak and write English to a good standard with familiarity of English medical terms
  • Good knowledge of PV related regulation

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