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 email@example.com, quotingjob ref 49525.
It is essential that applicants hold entitlement to work in the UK.