Our client is a publicly owned international pharmaceutical company and has a broad expertise in the acquisition and licensing of pharmaceutical and healthcare products and delivering these to patients.
For this client, we are currently looking for this permanent position in Dusseldorf:

Pharmacovigilance Manager (m/f) DACH & EEA Deputy QPPV (Stufenplanbeauftragter, Informationsbeauftragter)

Vertragsart: Festanstellung

Auftragsnummer: A389-654

Startdatum: 01.04.2018

Einsatzort: Nordrhein-Westfalen

Job-Beschreibung:


Ihre Aufgaben:

  • Hold legal and persona liability in DACH region as Stufenplanbeauftragter.
  • Responsible for DACH pharmacovigilance activities.
  • Ensure awareness of changes to legislation and guidelines and adapt the systems and processes as required.
  • Manage, maintain and develop the DACH and Group pharmacovigilance system, including the provision of expert training and advice under guidance of QPPV
  • Following agreement with QPPV, lead the development and implementation of pharmacovigilance strategies as aligned to business strategy
  • Conduct routine monitoring of AEs and provide continuous process improvement recommendations to QPPV.
  • Input into the preparation of regulatory action in response to emerging safety concerns, oversee the preparation of PSURs and other regulatory documentation and conduct final approval for DACH products or as requested by QPPV for other products .
  • Interact with DACH regulatory agencies, consultants, contractors and International partners
  • Provide pharmacovigilance advice to cross-functional project teams
  • Represent or lead Pharmacovigilance on assigned cross-functional project teams and ensure project teams and business objectives are aligned with pharmacovigilance strategy
  • Responsible for negotiation in varied situations, both internally and externally, in order to reach appropriate resolution
  • Coaches, mentors, develops, any directly supervises personnel, and advises other team members
  • Deputise for EEA QPPV
  • Hold legal and personal liability in DACH region (Informationsbeauftragter)
  • Responsible for DACH Medical Information activities.
  • Responsible for the maintenance and QC of DACH product information in German language
  • Following agreement with group Medical Information Manager, lead the development and implementation of Medical Information strategies as aligned to business strategy for DACH
  • Interact with DACH regulatory agencies, consultants, contractors and International partners
  • Where requested by group Medical Information Manager, participate in potential and established third party ventures (due diligence, joint ventures etc)
  • Responsible for implementing DACH operational and strategic policies and directives within the medical Information team/department as directed by group Medical Information Manager

Ihre Qualifikationen:

  • Degree in Pharmacy, medicine or other natural scientist
  • Excellent knowledge of PV regulations and guidelines
  • Profound pharmaceutical industry and PV experience (at least 5 years),
  • Ability to process information, analyze data and to reach conclusions based on sound reasoning
  • Clear and comprehensive communication skills
  • Proficiency for MS Office applications and other relevant software platforms
  • Analytical way of thinking combined with flexibility and structured working attitude
  • Excellent written and verbal communication skills in German and English
  • Exact and reliable way of working
  • Strategic thinking