Drug Safety Specialist - 6 months FTC

This is a great opportunity for a Drug Safety Specialist to join a global pharmaceutical company for 6 months contract. 

To be successful in this role, you will need to have prior experience in both Pharmacoviglance case processing and reporting. You will be well versed in the Eudravigilance Modules (on case processing) and writing case narratives; and happy to sit a quiz on such areas as part of the application process.

As a Drug Safety Specialist within this innovative organisation, you will triage incoming AE reports and evaluate ICSRs to ensure regulatory compliance. Located on the outskirts of West London you will be part of a team of Pharmacovigilance specialists, working on clinical trials and ensuring regulatory reporting compliance.

Responsibilities

• SAE case processing and evaluation
• Triaging Case reports and writing case narratives
• Enter SAE reports into the company system
• Identify SUSARs from blinded clinical studies
• Submission and tracking of ICSRs, reviewing source documents
• Utilise ARISg

You will benefit from joining a leading pharmaceutical organisation who are definitely on the rise; they are due launch a number of new major drugs in the coming years and their EMEA team is expanding rapidly. Whilst working as a contractor, they will treat you very much as an essential resource to the business alongside their permanent team.

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.

Drug safety specialist, drug safety, pharmacovigilance, clinical trials, FDA, EMA, ICH guidelines, PV