CK Group are looking for a Clinical Safety Scientist for a role requirement based in Uxbridge on a contract basis. This role will be part of the respiratory safety function.
A Global Pharmaceutical company with an extensive portfolio of medicines both on the market and in clinical development.
Stockley Park area, Uxbridge
- Conduct signal detection for assigned products using available methodologies.
- Drive production of periodic regulatory documents (PSURs, DSURs) according to the agreed process and timelines.
- Produce regulatory supporting documentation for labelling updates.
- Produce accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data.
- In consultation with the product physician and Clinical Development representatives, prepare the Development Core Safety Information (DCSI) for assigned development products.
- Advise on strategy for the content of PSURs and in preparation of license renewal documentation (e.g. PSUR addenda line listings, clinical overviews, summary bridging reports).
Extensive experience working in a drug safety / surveillance / pharmacovigilance.
Ideally experience of working within respiratory disease (this is ideal not a pre-requisite).
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 KA43035 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: KA43035
- Updated: 8th August 2018
- Expires: 5th September 2018