Drug Safety Specialist-12 month contract

Recruiter
Park Street People
Location
Heathrow
Posted
12 Jan 2018
Closes
13 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time

This is a great opportunity for a Drug Safety Specialist to join a global pharmaceutical company to work on both pre-and post-market activities in clinical trials.

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 Module IV (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
  • Utilise ARISg
  • Identify SUSARs from blinded clinical studies
  • Submission and tracking of ICSRs, reviewing source documents.

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.

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