Pharmacovigilance Specialist
- leeds, west yorkshire, LS1 1UR, United Kingdom
- Permanent·Remote
- Full time
- £58,000 - £58,000 Per Annum
Job Description
About the Role
Our client is seeking a diligent and detail-oriented Pharmacovigilance Specialist to join their safety surveillance team, operating entirely on a remote basis. In this role, you will be crucial in monitoring the safety of pharmaceutical products post-marketing, ensuring compliance with global regulatory requirements. You will be responsible for the collection, assessment, and reporting of adverse event data, contributing to the overall safety profile of our client's pharmaceutical portfolio. This position requires a strong understanding of safety reporting systems and a commitment to patient safety, all managed within a flexible, work-from-home framework. You will work closely with regulatory, medical, and clinical teams to maintain the highest standards of drug safety.
Key Responsibilities
- Collect, process, and evaluate adverse event reports from various sources.
- Ensure timely and accurate reporting of safety information to regulatory authorities and internal stakeholders.
- Contribute to the preparation of aggregate safety reports, such as Periodic Safety Update Reports (PSURs).
- Maintain and update safety databases with relevant case information.
- Participate in the development and review of safety-related documents and procedures.
- Collaborate with internal departments and external partners on safety matters.
Requirements
- Bachelor's degree in a healthcare-related field (e.g., Pharmacy, Nursing, Life Sciences).
- Proven experience in pharmacovigilance or drug safety operations.
- Familiarity with global safety reporting regulations and guidelines (e.g., FDA, EMA).
- Experience with safety database systems (e.g., Argus, ArisG).
- Strong analytical skills and meticulous attention to detail for data accuracy.
- Ability to work independently and manage workload effectively in a remote environment.
Benefits
- Competitive salary and annual bonus.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holidays.
- Support for professional development and continuous learning in pharmacovigilance.
- Flexible remote working schedule, allowing for work-life balance.
- Access to leading safety software and resources for effective case management.