Are you an experienced Drug Safety Scientist? Are you looking to take on a new challenge with a leading Pharma giant? If so we are looking for individuals just like you!
We are looking for a Drug Safety Scientist to support the coordination of safety reporting requirements as required for marketing authorisation holders and /or the study sponsor. You will be working on the receipt and processing of incoming safety information from multiple sources, both internal and external.
This opportunity is a 12 month contract role, working 37 hours per week Mon-Fri.
- 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
- Assist with assessment of incoming information from multiple sources, both internal and external to the Company
- Assist in the quality review of data captured in the Global Safety Database
- Continual monitoring and assessment of reportability of Individual Case Safety Reports due for regulatory reporting to the respective Competent Authorities (MHRA and IMB) and Notified Bodies such as the British Standards Institution
- Quality review of expedited assessments prior to submission
- Provision of safety information to Competent Authorities/Notified Bodies within required regulatory timelines
- Degree-level qualification (ideally in life science) or equivalent 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
- Fluency in English language required
- Occasionally flexible working hours
- Basic level Word & Excel are essential
- Basic level PowerPoint desirable
- Intermediate level Excel desirable
If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
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