Job Title: Qualified Person Responsible for Pharmacovigilance (QPPV)
Location: Remote (Employees can work remotely)
Job Type: Full-time
Department: QPPV Department
About the Company:
PrimeVigilance, part of Ergomed PLC, is a specialized pharmacovigilance service provider established in 2008. The company has achieved consistent global organic growth, with staff based across Europe, North America, and Asia, covering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance serves small to large pharmaceutical and biotechnology companies, becoming a global leader in its field. The company operates across all therapy areas, including medical devices, and is committed to employee well-being, development, and work-life balance.
Job Responsibilities:
Safety Management and Reporting:
Establish and maintain a system to collect and collate information on suspected adverse reactions
Ensure that all requests from Competent Authorities (CAs) for additional information are answered promptly and fully
Provide relevant information to CAs regarding the evaluation of medicinal product benefits and risks, including post-authorisation safety study information
Regulatory Liaison and Oversight:
Be continuously available to CAs in Member States, the Agency, and the Marketing Authorization Holder (MAH)
Ensure back-up procedures are in place for seamless communication and operations
Oversee safety aspects of the company’s medicinal products, including safety profiles, emerging safety concerns, and marketing authorisation obligations
Strategic Oversight and Compliance:
Monitor the company’s safety operations, including any conditions or obligations adopted as part of marketing authorisations
Ensure compliance with safety surveillance regulations and pharmaceutical industry standards
Required Qualifications:
Education:
Life-science education background, with Medicine (human or veterinary) or Pharmacy preferred
Experience:
Solid knowledge of pharmacovigilance system operations and functions
Strong knowledge of global regulations, safety reporting, and pharmaceutical industry compliance
Proven experience in a pharmacovigilance role, with profound experience as a QPPV
Skills:
Strong oral and written communication skills in English
Strong operational and managerial skills, demonstrated by leading previous projects or functions
Additional Information:
PrimeVigilance prioritizes diversity, equity, and inclusion, fostering an equal opportunities workplace.
The company emphasizes a human-first approach, recognizing that its people are the key to its continued success in improving lives.
PrimeVigilance offers internal training and career development opportunities, a supportive working environment, and the chance to work with colleagues from across the world.
Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Auckland |New Zealand :
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Croatia |Zagreb :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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