Qualified Person Responsible for Pharmacovigilance, EU and UK

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

📋 Description

• Develop and uphold a system that guarantees information regarding suspected adverse reactions is gathered, organized, and readily available within the Community.

• Ensure that requests for additional information from competent authorities are addressed thoroughly and promptly.

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

• Remain perpetually accessible to competent authorities in Member States, the Agency, and the marketing authorisation holder.

• Ensure that sufficient back-up procedures are established.

• Supervise safety considerations concerning the company’s medicinal products.

• Maintain an overview of the safety profiles of medicinal products and any emerging safety issues.

• Monitor conditions of marketing authorisation, obligations, safety commitments, and relevant findings from studies/programs.

⛳️ Requirements

• Background in life sciences education.

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

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

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

• Demonstrated strong operational and managerial skills through previous project or function leadership.

• Significant experience in a pharmacovigilance role.

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

• Excellent oral and written communication skills in English.

• Must reside in the United Kingdom or Romania.

🏝️ Benefits

• Opportunities for training and career advancement within the organization.

• Strong focus on personal and professional development.

• Supportive and friendly working atmosphere.

• Chance to collaborate with colleagues from around the globe.

• English is the primary language used in the company.

• Equal opportunity workplace.

• Human-centered work environment.

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

• Healthy work-life balance.