Drug Safety and Risk Management Specialist in Uxbridge

Up to £25 per hour
18 Jun 2019
18 Jul 2019
Hendre Moolman
Full Time
Contract Type
Experience Level
Hendre Moolman at CK Group is recruiting for a Drug Safety and Risk Management Specialist to join a biopharmaceutical company at their site based in Stockley Park on a 1 year contract.

The Company:
A global biopharmaceutical company who are committed to helping patients who are living with a wide range of debilitating and chronic diseases, from cancer to psoriasis.

The Location:
The role is based at our client's site in Uxbridge which is easily commutable from central London and the Home Counties region, with great commuter and international travel links.   

The Role:
The main purpose of the role will be to:
- Assist with delivery of ongoing activities and enhancing the Risk Management Plan for the company's products.
- Oversee and execute timely local case-processing activities, including ensuring robust investigation and follow-up of local safety reports for both marketed products and those under development.
- Ensure the accurate, timely and complete receipt, evaluation and follow- up of domestic adverse event reports.

Further responsibilities will include:
- Ensuring compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilising ARISg and E2B.
- Preparation and review of Drug Safety processes and documentation including SOPs/WPs and work aids.
- Ensuring the reconciliation activities are performed in a timely manner as per local processes.

Your Background:
To succeed in this role, you will come from a Life Science background with previous relevant experience within a Pharmaceutical company or CRO.
- Ability to follow standard operating procedures, with a high attention to detail.

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 45827 in all correspondence.