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 jgleeson@ckclinical.co.uk, quotingjob ref 49525.

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

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