Description
Responsibilities include (not limited to):- Development and maintenance the companies pharmacovigilance system and to maintain it in compliance with EU requirements.
- Provide safety input for post-authorisation studies and in particular to be accountable for post-authorisation safety studies.
- Act as single point of contact for Competent Authorities on a 24-hour basis.
- Review and sign off regulatory documents requiring input from the Qualified Person Maintain links within company to ensure timely transfer of information. - Line management of a several team memebers managing devices safety and PV (Clinical Trial and Post Marketing)
The ideal candidate will have:
- BSc - Over 8 years of experience in pharmacovigilance
- Solid track record working with the MHRA
- Thorough understanding and working knowledge of GMP/GCP/GPvP
- GPVP auditing experience
- Previous EEA/EMEA QPPV experience- MUST HAVE A RIGHT TO WORK IN THE UKSthree UK is acting as an Employment Agency in relation to this vacancy.