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 uphold a system that guarantees the collection, organization, and accessibility of information regarding all suspected adverse reactions within the Community.

• Ensure that requests from competent authorities for additional information regarding benefit-risk evaluations are addressed thoroughly and promptly.

• Provide competent authorities with pertinent information related to the benefit-risk evaluation of medicinal products, including planned post-authorisation safety studies.

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

• Ensure that adequate backup procedures are established and maintained.

• Supervise safety aspects associated with the company’s medicinal products.

• Keep an overview of the safety profiles of medicinal products and any emerging safety concerns.

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

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

⛳️ Requirements

• Background in life sciences education.

• Preferred qualifications in Medicine (human or veterinary) or Pharmacy.

• Comprehensive understanding of the operations and functions of pharmacovigilance (PV) systems.

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

• Demonstrated strong operational and managerial skills through leadership in 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 development within the organization.

• Strong focus on personal and professional growth.

• A friendly and supportive working environment.

• Chance to collaborate with colleagues from around the globe.

• Commitment to equal opportunities in the workplace.

• A human-centric work atmosphere.

• English is the official language of the company.