Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU and UK (homebased)

Added
25 days ago
Type
Full time
Salary
Salary not provided

Related skills

english regulatory affairs global regulations pharmacovigilance adverse event reporting

πŸ“‹ Description

  • Establishment and maintenance of a system to collect and collate information about all suspected
  • Ensure requests from Competent Authorities (CAs) for additional information needed for evaluating
  • Provide CAs with other information relevant to the evaluation of benefits and risks, including
  • Be continuously available to CAs in Member States, the Agency, and the MAH, ensuring adequate
  • Oversee safety aspects of the company’s medicinal products, including safety profiles, emerging

🎯 Requirements

  • Life-science education background, Medicine (human or veterinary) or Pharmacy preferred
  • Solid knowledge of PV system operations and function
  • Strong knowledge of Global Regulations, standards and best practices regarding safety processing
  • Strong operational and managerial skills as demonstrated by leading previous projects or functions
  • Strong experience in a PV role, with profound experience as QPPV
  • Strong oral and written English communication skills

🎁 Benefits

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language
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