PV Compliance Associate
Salary: Up to 30,000 + Benefits
We have an excellent new opportunity for a PV/Drug Safety Associate to join a growing PV function within a small, Surrey based pharmaceutical company. As a PV Compliance Associate, you will be required to ensure that all PV activities are conducted in compliance with regulatory requirements and internal SOPs.
Management of quality aspects of PV activities such as the management of PV quality documents (i.e. Standard Operating Procedures (SOPs), Working Instructions (WIs), PV System Master File (PSMF).
Control of internal PV compliance processes and regulatory requirements (e.g. Case processing, Follow-up management, reconciliation, filing & archiving)
Produce quality and compliance metrics reports
Track CAPA deliverables, timely investigation and responses to deviations
Support the wider PV team when performing root cause analysis for any deviation and review all deviations and CAPAs before logging with QA department.
Participate in activities relating to inspections and internal PV audits
Maintain PV team training matrix, training folders and ensure training records are maintained in up to date in line with SOPs, QA training matrix requirements.
Minimum 2 years' experience in pharmacovigilance compliance/quality fields
Good working knowledge of EU GVP guidelines
Strong knowledge of ICP GCH guidelines
Excellent written & verbal communication skills
Life science degree
This is a permanent position that will offer training and development to the right person who exhibits a good attitude and a strong work ethic. The company have a hybrid working model, offering 3-4 days home-working alongside your base salary and additional benefits. 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-2107-472533
Website: Cpl Life Sciences
- Posted: 15th July 2021
- Expires: 12th August 2021