Pharmacovigilance Associate

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.