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

📋 Description

• Establishment and maintenance of a system for collecting and collating information about all
• Ensuring requests from Competent Authorities for additional information are answered fully and
• Providing CAs with information relevant to evaluation of benefits and risks, including planned
• Being continuously available to CAs and MAH, with proper back-up procedures
• Oversight of safety aspects of the company's medicinal products
• Overview of medicinal product safety profiles, emerging safety concerns, conditions/obligations

🎯 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 demonstrated by leading previous projects or functions
• Strong experience in a PV role, 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 worldwide, with English as the company language