CK Group are recruiting for a Drug Safety Scientist to join a company in the pharmaceutical industry at their site based in Maidenhead on an 18 month contract.
The main purpose of the role will be to:
-Support the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs) and/or study sponsor, as applicable.
Further responsibilities will include:
Inbound Case Management:
-Receipt and processing of incoming safety information from multiple sources, both internal and external to the Company
-Entry of relevant/required safety data into the Global Safety Database from spontaneous sources, clinical trials and other solicited sources.
-Provision of safety information/acknowledgement to marketing partners/other third party partners/Global Medical Safety within the internal and contractual timelines
-Requesting additional information from multiple sources, both internal and external to the Company
-Assisting with assessment of incoming information from multiple sources, both internal and external to the Company
-Assisting in the quality review of data captured in the Global Safety Database
Outbound Case Management:
-Continual monitoring and assessment of reportability of Individual Case Safety Reports due for regulatory reporting to the respective Competent Authorities and Notified Bodies
-Quality review of expedited assessments prior to submission
-Accurate and timely documentation of deviations to process/timelines. Including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs)
-Supporting all occurrences of internal and external audits and inspections
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Degree-level qualification (ideally in life sciences) or equivalent nursing qualification
-Awareness of and familiarity with industry principles of drug development and pharmacology
-Proficiency in global and local SOPs
-Computer literate with expert knowledge of the Global Safety Database and/or expedited reporting module(s)
-Ability to prioritise and work to strict timelines on a daily basis
-Excellent verbal and written communication skills
-Ability to negotiate and communicate with internal and external customers
-Ability to work effectively as a member of the Drug Safety and broader Medical Department teams
-Knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland
-Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable
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 KA41839 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 17th April 2018
- Expires: 15th May 2018
- Reference: KA41839