PV/Drug Safety Associate
Growing Pharma Company
Salary: Up to 30,000 + Benefits
My client is an exciting, biopharmaceutical business focused on the development and commercialisation of drugs to treat metabolic and genetic diseases. They have an urgent need for a PV Associate to join their team on a permanent basis.
The primary objective of the PV Associate will be to perform activities in the scope of ICSR management unit within agreed frameworks and timelines as required.
Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with regulatory requirements and Company SOPs
Performing ICSR follow up
MedDRA coding of safety data to the current version as required
Maintenance of PV database
Monitoring AEs arriving via disease registry
Database outputs and reports in the required format
ICSR and SUSAR reporting to regulatory authorities
Assist in the ongoing improvements of internal PV systems
Prior experience of PV case processing within a UK Pharma/CRO or biotech environment
Strong knowledge of GVP guidelines
Working knowledge of ICH GCP guidelines
Knowledge of, and training in, MedDRA coding
Knowledge of pharmacovigilance software and processes
This is a permanent role, based in Surrey, offering 2-3 days' home-working although currently fully remote. The successful applicant will be rewarded with a competitive salary and benefits as well as playing a pivotal role in the growth of the business.
If this role is of interest, please send your CV to George.Danchie@cpl.com or call 0118 959 4990 for more information.
- Agency: Cpl Life Sciences
- Contact: George Danchie
- Reference: JO-2107-472523
Website: Cpl Life Sciences
- Posted: 14th July 2021
- Expires: 11th August 2021