Pharmacovigilance Specialist
2 months ago
Cheltenham, Gloucestershire, United Kingdom
Pharma Partners Recruitment Ltd
Full time
Job SummaryWe are seeking a highly skilled Pharmacovigilance Specialist to join our team at Pharma Partners Recruitment Ltd. As a key member of our Medical Affairs team, you will play a critical role in ensuring the safety of our clients' products.
Key Responsibilities- Safety Data Management: Review and analyze safety data received from various sources, including spontaneous reports, literature sources, and regulatory authorities.
- Literature Review: Conduct systematic reviews of safety information published in the scientific literature, in partnership with third-party service providers.
- Case Processing: Process and assess Individual Case Safety Reports (ICSRs), including data entry and triage.
- Signal Management: Detect, assess, and recommend actions for potential safety signals.
- Risk Management and Minimization: Develop and maintain Risk Management Plans, and implement risk minimization activities, including product labeling and additional materials.
- Aggregate Safety Reports: Author, co-author, and review aggregate safety reports (PSURs, PBRERs) with the Medical Affairs team.
- Product Maintenance and Development: Author safety-related information, including updates to product labeling, and coordinate regulatory activities.
- A degree in Biological or Biomedical Sciences, with a postgraduate degree an advantage.
- Relevant experience in Pharmacovigilance and Medication/Patient Safety.
- Clear understanding of current and developing legislation, ethics, and practice, with the ability to apply this to company processes.
- Outstanding communication and medical writing skills, with exceptional attention to detail.
- Ability to build and maintain effective working relationships with cross-functional and multi-national colleagues.
- Ability to meet deadlines while managing multiple responsibilities.
- Professionalism and integrity.
- Competitive basic annual salary plus benefits package.