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.