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 suspected adverse reaction information within the Community.

• Ensure that requests from regulatory authorities for additional information are responded to comprehensively and in a timely manner.

• Provide regulatory bodies with pertinent information necessary for assessing the benefits and risks of medicinal products, including planned safety studies post-authorization.

• Be consistently available to regulatory authorities, the Agency, and the marketing authorization holder.

• Implement sufficient back-up procedures.

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

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

• Monitor conditions, obligations, safety commitments, and relevant findings from company studies and programs.

⛳️ Requirements

• Background in life sciences education.

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

• Comprehensive understanding of the operations and functions of pharmacovigilance systems.

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

• Proven operational and managerial abilities demonstrated through leadership in previous projects or functions.

• Significant experience in a pharmacovigilance role.

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

• Excellent oral and written communication skills in English.