Pharmacovigilance Associate

  • Salary: £30,000 - £40,000
  • REF Number: 00049525
  • Consultant: Jim Gleeson
  • Contact: 01438 842973
  • Date Published: 07.01.2021
  • Closed Date: 15.01.2021
  • Sector: Non-Specific
  • Location: West Sussex, South Coast
  • Discipline: Drug Safety And Pharmacovigilance

CK Clinical are recruiting for a Pharmacovigilance Associate to join a well-established, global CRO, based from their site in West Sussex.

Salary: Base salary up to £40,000 per annum.

Pharmacovigilance Associate Role: As Pharmacovigilance Associate you will play a key role in the processing of SAE reports according to study protocol and sponsor requirements.

Key duties will include:

  • Review of SAE reports and any supporting documents for accuracy and completeness.
  • Entering safetydata into the Safety Database and preparing patient narratives.
  • Coding Serious Adverse Events accurately using MedDRA.
  • Ensuring cases receive appropriate medical review.
  • Ensuring cases that require expedited reporting to regulatory agenciesare processed within the timelines identified in the SMP.
  • Preparation of safety reports for Sponsor approval, regulatory submission and investigator notification.
  • Submission of safety reports to regulatory agencies, Central Ethics Committees and Investigators, as required.
  • Maintaining study-specific records for SAEs and safety reports, including the safety database.

Your Background: As Pharmacovigilance Associate you will require:

  • Life Sciences degree, Nursing background or equivalent.
  • Case processing experience and being used to working with SAEs and SUSARs.
  • Experience of using ARGUS or a similar clinical database.
  • Experience of having acted as a Responsible or Qualified Person for Eudravigilance will be advantageous.
  • A strong knowledge of ICH-GCP and medical and drug terminology.

Apply: For more information or to apply for this Pharmacovigilance Associate position, please contact Jim Gleeson on 01438 842973 or email, quotingjob ref 49525.

It is essential that applicants hold entitlement to work in the UK.

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