Candidatul ideal

• Solid understanding of EU regulatory requirements and good PV practices.
• 3 to 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

Descrierea jobului

• 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.

Descrierea companiei

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.