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

Added
7 days ago
Type
Full time
Salary
Salary not provided

Related skills

english global regulations pharmacovigilance pv operations qppv

๐Ÿ“‹ Description

  • Establish and maintain a system ensuring collection and collation of all suspected adverse reaction
  • Ensure full and prompt response to Competent Authorities (CAs) requests for additional information
  • Provide CAs with other information relevant to benefits and risk evaluation, including appropriate
  • Be continuously available to CAs in Member States and the Agency and the MAH, ensuring adequate
  • Have oversight of safety aspects of the company's medicinal products, including medicinal product

๐ŸŽฏ 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, profound experience as QPPV
  • Strong oral and written English communication skills

๐ŸŽ 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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