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Drug Safety Scientist x2

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Are you looking for your next challenge within Drug Safety? 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 qualificationFluency in English language required.Must have a valid UK working VISA.

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Posted 22 days ago

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