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Pharmacovigilance Officer
- glasgow, scotland, EH1 2HL, United Kingdom
- Full time
- £50,000 - £50,000 Per Annum
Job Description
About the Role
Our client is seeking a diligent and observant Pharmacovigilance Officer to join their safety monitoring team in Edinburgh . This role is crucial for safeguarding public health by ensuring the safe use of pharmaceutical products. You will be responsible for the accurate collection, assessment, and reporting of adverse event data, contributing to the overall safety profile of our client's medicines. The ideal candidate possesses a strong scientific background, meticulous attention to detail, and a thorough understanding of pharmacovigilance regulations. Working within a supportive team, you will help maintain regulatory compliance and contribute to the ongoing assessment of drug safety throughout their lifecycle.
Key Responsibilities
- Collect, process, and evaluate adverse event reports from various sources.
- Determine reportability and ensure timely submission of safety data to regulatory authorities and partners.
- Conduct signal detection activities to identify potential new safety concerns.
- Contribute to the preparation of aggregate safety reports, such as PBRERs and DSURs.
- Liaise with internal departments and external stakeholders on safety-related matters.
- Maintain accurate and organized safety databases and documentation.
Requirements
- Bachelor's degree in a life science, nursing, pharmacy, or related healthcare field.
- Minimum of 3 years of experience in pharmacovigilance or drug safety.
- Solid understanding of global pharmacovigilance regulations and guidelines (e.g., GVP, FDA regulations).
- Experience with safety database systems (e.g., Argus, ArisG).
- Proficiency in medical terminology and case processing.
- Strong analytical skills and the ability to manage detailed information accurately.
Benefits
- Competitive salary and annual performance review.
- Comprehensive health, dental, and vision insurance coverage.
- Generous pension scheme.
- Paid training and development opportunities in pharmacovigilance .
- A supportive and collaborative team environment dedicated to patient safety in Edinburgh .