Full-Time Qualified Person Responsible for Pharmacovigilance (QPPV)

EU QPPV Responsibilities:

• Establish and maintain a system for collecting and collating suspected adverse reaction reports from company personnel and medical representatives, ensuring accessibility within the EU.
• Fully and promptly answer requests from CAs (Competent Authorities) for additional information on medicinal product benefits and risks.
• Provide CAs with relevant information about medicinal product benefits, risks, and planned post-authorization safety studies.
• Maintain continuous availability to CAs in Member States, the Agency, and the MAH (Marketing Authorization Holder), ensuring adequate backup procedures.
• Oversee the safety aspects of the company's medicinal products: including medicinal product safety profiles, emerging safety concerns, conditions/obligations from marketing authorizations, and safety-related commitments/findings from company studies/programs.

Qualifications:

• Life-science education background (Medicine, Pharmacy preferred)
• Strong knowledge of PV system operations and function
• Solid knowledge of Global Regulations, standards and best practices regarding safety processing, reporting, surveillance and pharmaceutical industry compliance.
• Strong operational and managerial skills (proven through leading projects/functions)
• Strong experience in a PV role, profound experience as QPPV
• Strong oral and written English communication skills

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