Quality Person Responsible for Pharmacovigilance

Quality Person Responsible for Pharmacovigilance

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.

 

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.

 

Who we are?
ELC GROUP is a fully-fledged global regulatory partner, working with major pharmaceutical stakeholders for over a decade. Among several other services, ELC Group provides comprehensive pharmacovigilance services.

Job Category

QPPV

Job Location

Czech Republic, Romania

Job Type

Full Time

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