Head Of Pharmacovigilance - Berkshire
Stephanie Maccioni at CK Group is recruiting for a Head of Pharmacovigilance to join a world leading Pharmaceutical company based in Berkshire, on a full time, permanent basis.
The Head of Pharmacovigilance will assure patient safety by means of product safety reporting/surveillance and maintenance of the PV systems for these countries. The obligations of the role include compliance with all applicable procedures and processes in line with local PV legislation, allowing the company to maintain marketing authorisation of its products in these countries. Also, additionally in the case of BREXIT, will be the nominated UK Qualified Person for Pharmacovigilance (QPPV) in accordance with UK legislation.
As the Head of Pharmacovigilance , you will have the following responsibilities:
- To lead the local PV department, ensuring the management of PV relevant information received locally (e.g. ICSR collection, local processing, follow-up, reconciliation, documentation and archiving) including PV reporting to local Health Authorities is performed in line with regulations.
- Develop a culture and implement plans to continuously improve on effective PV activities.
- Ensure systems and processes are in place to facilitate the appropriate PV training of staff and those working in the respective countries.
- Give PV input to local/regional activities such as Compassionate Use Programmes, Non-Interventional Studies in liaison with Global Pharmacovigilance (GPV).
- Create and maintain local PV agreements (PVAs).
- Maintain PV knowledge to ensure we fully comply with PV relevant legislation.
- Advise local and Corporate senior management of any future legislative changes impacting on the business.
- Identify, investigate, report (to Medical Director/EUCAN Region PV Head) and rectify any potential areas of PV non-compliance during routine business or observations from PV audits and inspections.
Additional duties should Brexit proceed:
- Accountable to the MHRA in establishing, maintaining and continuously improving PV processes in the UK.
- Responsible for establishment and maintenance of a UK specific PV System Master File (PSMF) to cover the complete portfolio of marketed products in the UK.
- Overview of the safety profiles and any emerging safety concerns for medicines licensed in the UK.
- Single PV contact point for the MHRA on a 24/7 basis for all PV related matters, including product safety issues, PV non-compliance's and PV inspections.
- Liable in the case of critical PV non-compliance(s) due to local factors within control of the UK QPPV.
As the Head of Pharmacovigilance, you will have the following qualifications, skills and experience:
- Sound clinical and scientific background.
- Extensive knowledge of the Pharmaceutical Industry in general and PV environment specifically.
- In-depth knowledge of UK/Irish, European and international regulatory requirements in the area of PV, obtained through extensive experience in PV roles within the Pharmaceutical industry and/or within regulatory authorities.
Full job description is available upon request.
For more information or to apply for this position, please contact Stephanie Maccioni on 01438 768713 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45682 in all correspondence.