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QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE – (EU- QPPV)

  • Banking, Finance, Insurance, Accounting and Trade jobs
  • Management (incl. project, product management & human resources)

Description

ELC Group is looking for a qualified and experienced person to join us in the role of QPPV, based in Prague, Czech Republic or Cluj, Romania.

 

In this position you will:

  • Serve as EU QPPV for selected marketing authorisation holders and overseeing MAH pharmacovigilance systems and their quality systems.
  • Develop and maintain pharmacovigilance system as per the EU and global regulatory requirements for ELC and selected MAHs.
  • Provide training to PV staff, local safety officer and other relevant personnel in relation to pharmacovigilance updates and requirements.
  • Review risk management plan (RMP), tracked commitments, ensured appropriate implementation of additional PV activities.
  • Ensure preparation and submission of PSURs/PBRER as per regulatory requirements.
  • Participate in audits and inspections and ensured appropriate implementation of corrective and preventive actions.
  • Provide overall signal management including participation in drug safety review meetings.
  • Review and approve the Pharmacovigilance System Master File (PSMF).
  • Ensure compliance on ICSRs processing and reporting as per the EU requirements.
  • Communicate with EMA and other health authorities.

Specific Requirements

To be successful in this role you should have:

  • Solid understanding of EU regulatory requirements and good PV practices.
  • 5 years of EU Pharmacovigilance experience.
  • Excellent written and oral communication skills in English.
  • Good analytical thinking.
  • Highly organized, results driven, problem solver with ability to synthesize, organize and communicate safety data from various sources

Hard Skills

  • Business correpondence
  • Data Management
  • Auditing
  • Advanced language knowledge
  • Business Process Understanding

Soft Skills

  • Team-oriented
  • Responsible
  • Organized
  • Hands-on
  • Attention to detail