3 months ago
Job title: Senior Pharmacovigilance Scientist
A global pharmaceutical company focused within Oncology, Neurology and Rare Diseases are seeking a Senior PV Scientist. This role will ensure Pharmacovigilance activities are executed in line with EU and UK regulations as well as internal SOPs.
This role will focus on Pharmacovigilance activities related to local solicited programmes and management of PV contractual arrangements.
- Provide proactive support and advice to all functions within the business in relation to programmes such as the above, including by provision of training on PV aspects.
- Ensure that all the above programmes/ studies conducted in the UK and Ireland are executed in full compliance with the PV requirements of internal SOPs and EMA/MHRA regulation
- Provide at time of the PSMF data lock point update all relevant information to the Global Patient Safety group.
- Document and track deviations from PV processes and ensuring that appropriate CAPA are developed and implemented to address issues with compliance
- Lead the management of PV agreements (initiation, negotiation, production, implementation, maintenance and termination) and perform regular PV Agreements review & escalate any issue in due time
- Document and track deviations from PV processes and ensuring that appropriate CAPA are developed and implemented to address issues with compliance.
- Life science degree
- Minimum 5 years' experience in pharmacovigilance
- Knowledge of the NHS, MHRA, HPRA, the Pharmaceutical Industry
- Experience with managing PV requirements in solicited programmes and PV Agreements
Salary and benefits:
A competitive salary, annual bonus, private healthcare, pension and wider benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via email@example.com