Pharmacovigilance (PV) Compliance Manager - Buckinghamshire - Pharma Company - Competitive Salary.
Carrot Pharma Recruitment are working on behalf of a distinguished Pharma Company to recruit an experienced Pharmacovigilance Compliance Manager to join their dynamic team in a pivotal role.
My client is a Global Pharma who have a commitment to improving human health and well being throughout the world, working within core therapeutic area of oncology and immunology. At the forefront on innovative drug discovery my client is embarking on a period of rapid growth and product launch.
As Pharmacovigilance Compliance Manager you will be responsible for ensuring the Pharmacovigilance systems for the groups product range. You will be responsible for monitoring internal PV systems and procedure whilst ensuring they are consistently meeting compliance with regulations.
Duties will include
* Manage GDS compliance and support GDS with CAPA Management
* Carrying out QA reviews on all of modules of the PSMF ensuring they are consistently updated and relevant.
* Review and maintain procedures and working instructions (PSUR's, RMP'S and GVP)
* Develop and maintain QVP departmental procedures
* Perform regular gap analysis pre audit / inspection and audit PV systems.
* Update and maintain quality incident tracking systems and related QA documentations
* Perform gap analysis as part of inspection/audit preparation or audit of PV system and participate where required
To be considered for this role candidates will
* Bachelor's Degree in Life Science
* GVP compliance and quality systems experience
* Possess in depth knowledge of Global PV regulations (EMA, ICH and FDA Regulations)
* Extensive experience within Pharmacovigilance with experience gained within European and/or FDA PV inspections
* Experience in CAPA Management / GVP Process development and training
The role is offering a competitive salary plus an excellent benefits package alongside the opportunity to work for a truly progressive company who can offer an experienced PV Manager a platform for fast tracked career progression.
What should you do next?
To discuss further, please submit your current CV now! - interviews for this role will be held immediately
Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.