Qualified Person Responsible for Pharmacovigilance (QPPV), EU - UK

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Develop and maintain a comprehensive system to ensure the collection, organization, and accessibility of information regarding suspected adverse reactions within the Community.

• Respond fully and promptly to requests from competent authorities for additional information on the benefit-risk profile of medicinal products.

• Provide relevant information to competent authorities regarding the evaluation of medicinal product benefit-risk, including any planned post-authorisation safety studies.

• Maintain continuous availability for competent authorities in Member States, the Agency, and the marketing authorization holder.

• Ensure robust backup procedures are established and maintained.

• Supervise safety-related aspects of the company’s medicinal products.

• Keep an overview of medicinal product safety profiles and any emerging safety issues.

• Monitor safety conditions associated with marketing authorizations, obligations, and other safety-related commitments.

• Evaluate pertinent findings from studies and programs conducted by the company.

⛳️ Requirements

• Background in life sciences education.

• Preference for candidates with a degree in Medicine (human or veterinary) or Pharmacy.

• Strong understanding of pharmacovigilance (PV) system operations and functionality.

• In-depth knowledge of global regulations, standards, and best practices related to safety processing and reporting, safety surveillance, and compliance activities in the pharmaceutical industry post-marketing.

• Demonstrated strong operational and managerial skills, evidenced by previous leadership in projects or functions.

• Extensive experience in a PV role.

• Significant experience as a Qualified Person for Pharmacovigilance (QPPV).

• Proficient in both oral and written English communication.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• Strong focus on personal and professional growth.

• A friendly and supportive work environment.

• Chance to collaborate with colleagues globally.

• English is the primary language of the company.

• A workplace committed to diversity, equity, and inclusion, ensuring equal opportunities.

• A human-centric work atmosphere.

• Emphasis on employee experience, well-being, and mental health.

• Promotion of a healthy work-life balance.