Drug Safety Specialist - Cambridgeshire

DRUG SAFETY SPECIALIST

Location: Cambridgeshire

A rare opportunity to join a small dynamic team of drug safety experts as a Drug Safety Specialist helping to shape the direction of drug safety measures within a leading biopharm company. The team provides assurances that the pharmacovigilance system of the company is compliant not only with the company's standards, but with regulatory standards too, through monitoring, identifying necessary actions and facilitating, supporting or implementing them as appropriate.

You will be involved in managing individual case reports (SAEs, ADRs), reconciliation of SAEs, coding and data retrievals from the safety database and supporting the generation of periodic safety reports.

* Producing concise and accurate narratives
* Submission of safety reports to the relevant authorities
* Processing individual case safety reports
* Reconciliation of Serious Adverse Events
* Generating data listings from the safety database

The ideal candidate will have an undergraduate degree ( or equivalent) preferably within life sciences and the ability to read, understand and summarise medical source documents. We are able to consider both experienced medical workers with a keen interest in drug safety and experienced clinical safety associates along with recent graduates.

An understanding of regulations relevant to safety of drugs in development and post authorisations as well as knowledge of clinical research would be an advantage.

Excellent salary and benefits available, please call Matt Spiller on or email