3 months ago
Job title: Pharmacovigilance Compliance Lead
A global pharmaceutical company focused within Oncology, Neurology and Rare Diseases are seeking a Pharmacovigilance Compliance Lead. This role will focus on the provision of a comprehensive, accurate and timely local PV management service for the UK and Ireland, with a specific focus on the management of quality aspects of PV activities within the framework of all applicable internal policies.
- Ensure all PV activities are conducted within the framework and in full compliance with national regulatory requirements, the Good Pharmacovigilance Practices (GVP), internal SOPs and policies, Health and Safety requirements, the Medicines Act and Industry Codes of Practice, the ABPI Code of Practice.
- lead the continuous process development and improvement initiatives to ensure PV processes remain compliant against national & EU regulations
- Act as secretariat of the PV steering committee and support the LPVM in collecting information allowing the LPVM and QPPV oversight of the PV system in UK/I.
- Maintain PV team training matrix, training folders and ensure training records are maintained in up to date in line with SOPs, QA matrix/GPS training matrix requirements.
- Perform Quality Checks to ensure compliance of local UK/I PV processes and GPS procedures, local regulations and company requirements (e.g. Case Logging, Follow-up management, Literature management, AE tracking systems, reconciliation, filing & archiving).
- Participate in activities related to coordinating Regulatory Authority Inspection, Internal Audit activities related to PV and risk-based audit programme for PV third parties, including but not limited to planning, document request preparation, tracking, filing, scribing, CAPA tracking, Effectiveness checks.
- Life science degree
- At least 3 years' experience in pharmacovigilance compliance/quality fields
- Knowledge of the NHS, MHRA, HPRA, the Pharmaceutical Industry
- Ability to analyse and communicate on technical pharmacovigilance processes
Salary and benefits:
A competitive salary, annual bonus, private healthcare, pension scheme and wider benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org