Drug Safety & MI Manager - Hemel Hempstead
Hendre Moolman is recruiting for a Pharmacovigilance and Medical Information Manager to join a speciality pharmaceutical company at their site based in Hemel Hempstead on a permanent basis.
The main purpose of the role will be to:
- Assist and support the ongoing aggregate review and analysis of product safety data
- Assist the PV vendor in the preparation of aggregate safety data
- Work on signalling reports, PSURs, DSURs, Annual Safety Reports, and reports to support internal/external data safety monitoring boards.
Further responsibilities will include:
- Supporting Risk Evaluation and Mitigation Strategy (REMS) plans
- Working on SDEA maintenance, Pharmacovigilance Plans, and other safety surveillance activities.
- Assisting in signal evaluation and the management of responses to regulatory agencies related to the assigned product.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Life science background
- Extensive medical writing, editing, and source document review experience
- Demonstrated ability to independently manage complex projects with multidisciplinary teams
This is an excellent opportunity to join a growing team in the UK affiliate
Benefits include a competitive salary with bonus and additional benefits.
For more information or to apply for this position, please contact Hendre Moolman on 01438 842 970 or email firstname.lastname@example.org. Alternatively, please click on the link below 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 shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL38776 in all correspondence.