Senior Clinical Drug Safety, Contract

£30-40 per hour
07 Aug 2019
03 Sep 2019
Hendre Moolman
Clinical Research
Full Time
Contract Type
Experience Level
Senior Management
Hendre Moolman at CK Group is recruiting for a Senior Clinical Drug Safety to join a company in the pharmaceutical industry at their site based in Harlow on a contract basis.

The Company:
Our client is a successful consultancy who provide end-end Regulatory and Drug Safety services across the product lifecycle for a wide range of clients.

The Location:
The role is based at our client's site in Harlow which is easily commutable from London and Hertfordshire, with offices located opposite the train station. Harlow offers everything from arts, culture and theatre to sport, parks and nature reserves.

The Role:
The main purpose of the role will be to:
- Support the PV Team Leaders and Management Team in ensuring that day to day operational activities are completed.
- Submission of SAEs and SADRs in the appropriate format to the Regulatory bodies, in compliance with the statutory timelines.
- Preparation, review and submission of Development Safety Update Reports (DSUR).

Further responsibilities will include:
- Updating and adding clients' products to the EVMPD (EudraVigilance Medicinal Product Dictionary).
- Triage and QC sign-off of AEs, AESIs, SAEs and SADR reports.
- Review Reference Safety Information section of the Investigator's brochure.

Your Background:
To succeed in this role, you will come from a Life Science background with proven experience working in clinical trial pharmacovigilance. Knowledge around Pharmacovigilance and the regulations governing the field would be required. Clinical Trial Management experience would also be beneficial.

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 46241 in all correspondence.

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