Qualified Person Responsible for Pharmacovigilance (QPPV) - Home Based

About the role

PrimeVigilance, part of Ergomed PLC, is looking for a Qualified Person Responsible for Pharmacovigilance (QPPV) to cover both the EU and the UK. The position is home-based and full-time. The QPPV is responsible for the safety of the company's medicinal products and for responding to requests from competent authorities.

Key responsibilities

• Establish and maintain a system that collects and collates information on suspected adverse reactions reported to the company and to medical representatives, so it is accessible at least once within the Community
• Answer fully and promptly any requests from competent authorities for additional information needed to evaluate the benefits and risks of a medicinal product, including planned post-authorisation safety studies
• Be continuously available to competent authorities in Member States and the Agency, the marketing authorisation holder and the company, with adequate back-up procedures in place
• Oversee the safety aspects of the company's medicinal products, including safety profiles, emerging safety concerns, conditions attached to marketing authorisations and findings from studies and programmes run by the company

Required profile

• Life-science education background; medicine (human or veterinary) or pharmacy preferred
• Strong experience in a pharmacovigilance role and as QPPV
• Strong oral and written English

Required skills

• Solid knowledge of pharmacovigilance system operations and function
• Strong knowledge of global regulations, standards and best practices for safety processing and reporting, safety surveillance and post-marketing compliance
• Operational and managerial skills, demonstrated by leading previous projects or functions

What we offer

• Training and career development opportunities internally
• A friendly, supportive working environment
• The chance to work with colleagues from all over the world, with English as the company language