Senior Pharmacovigilance Scientist
Hendre Moolman is recruiting for a Senior Pharmacovigilance Scientist to join a company in the pharmaceutical sector at their site based in Hertfordshire on a full time, permanent basis.
This is an excellent opportunity to join a company that is committed to research and development to maintain a key position in a constantly changing market, specialising in wide range of plasma based products, offering a competitive salary, bonuses and benefits.
The main purpose of the role will be to:- Assume responsibility for the scheduling, production and distribution of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and thereby contributing to the regulatory compliance.
- Provide pharmacovigilance support for ongoing clinical trials and DSUR
Further responsibilities will include:
- Perform 'Quality Review' and 'follow up' activities for individual case reports, escalating any product safety concerns to the QPPV, and the Chief Medical Officer.
- Support internal and external audits of the PV system including maintenance of the PSMF
- Perform electronic reporting via EVWEB and FDA reporting portal for ICSRs and also XEVMPD submission
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Life Science Degree
- Strong experience in RMPs/PBRERS/PSURs/US Periodics/DSURs
- Strong background in Pharmacovigilance and excellent knowledge of global Pharmacovigilance regulatory obligations
- Medical Information experience
For more information or to apply for this role, please contact Hendre Moolman on 01438 842 970 or email firstname.lastname@example.org. Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer who 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 short listed for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL36529 in all correspondence.