Drug Safety Scientists
Our client based in Berkshire is now looking for an exceptional Drug Safety Scientist to join their team on a 12 month contract.
They are looking for a candidate to support the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs).
Responsibilities include (but are not limited to):
- Receipt and processing of incoming safety information from multiple sources, both internal and external to the Company.
- Entry of relevant/required safety data into the Global Safety Database from spontaneous sources, clinical trials and other solicited sources.
- Assist in the quality review of data captured in the Global Safety Database.
- Continual monitoring and assessment of reportability of Individual Case Safety Reports due for regulatory reporting to the respective Competent Authorities (MHRA and IMB) and Notified Bodies (British Standards Institution (BSI))
- Quality review of expedited assessments prior to submission.
- Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable.
- Degree-level qualification (ideally in life science) or equivalent qualification
- Fluency in English language required.
- Must have a valid UK working VISA.
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