QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE – (EU- QPPV)
- Banking, Finance, Insurance, Accounting and Trade jobs
- Management (incl. project, product management & human resources)
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
- Business correpondence
- Data Management
- Advanced language knowledge
- Business Process Understanding
- Attention to detail