Qualified Person Responsible for Pharmacovigilance, EU/UK

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

📋 Description

• Develop and uphold a system to ensure that suspected adverse reactions are systematically gathered, organized, and easily accessible within the Community.

• Respond comprehensively and promptly to requests for additional information from competent authorities.

• Supply competent authorities with pertinent information necessary for assessing the benefits and risks of medicinal products, including details on planned post-authorisation safety studies.

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

• Ensure that sufficient backup procedures are established and maintained.

• Supervise the safety aspects pertaining to the company’s medicinal products.

• Keep a comprehensive overview of the safety profiles of medicinal products and any emerging safety issues.

• Monitor the conditions, obligations, and safety commitments linked to marketing authorizations.

• Analyze relevant findings from studies and programs conducted by the company.

⛳️ Requirements

• Educational background in life sciences.

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

• Strong understanding of pharmacovigilance system operations and functions.

• 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 operational and managerial capabilities, evidenced by leading previous projects or functions.

• Extensive experience in a pharmacovigilance role.

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

• Excellent oral and written communication skills in English.

🏝️ Benefits

• Opportunities for training and career advancement within the organization.

• Strong focus on personal and professional development.

• A friendly and supportive work environment.

• Opportunity to collaborate with colleagues around the globe.

• English is the primary language used within the company.

• Commitment to providing equal opportunities in the workplace.

• A human-centric work atmosphere.

• Emphasis on diversity, equity, and inclusion.