drug safety scientist in high wycombe

posted
job type
contract
salary
£ 42,000 per year
apply now

job details

posted
location
high wycombe, buckinghamshire
job category
pharmaceutical
job type
contract
salary
£ 42,000 per year
reference number
DSSJJHW
apply now

job description

Are you looking for a new role as a Drug Safety Scientist? An outstanding opportunity has arisen for a Drug Safety Scientist of the highest calibre to join one of the world's largest pharmaceutical companies.

The successful Drug Safety Scientist will supporting the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs) and /or study sponsor, as applicable.

This role is for a 12 month full time contract, 37 hours per week.

Benefits:



* Free on site gym
* Free parking
* Weekly pay
* Holiday pay
* Pension plan
* On site restaurant and coffee shop

Duties:



* 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
* 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
* Outbound Case Management
* 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 (British Standards Institution (BSI))
* Quality review of expedited assessments prior to submission
* Provision of safety information to Competent Authorities/Notified Bodies within required regulatory timelines
* Accurate and timely documentation of deviations to process/timelines. Including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs)
* Support all occurrences of internal and external audits and inspections
* Ensures all assigned training is completed in a timely manner

Qualifications and experience:



* Degree-level qualification (ideally in life sciences) or equivalent nursing qualification
* Registration with official governing bodies e.g. General Medical Council, Royal Society of Pharmacists
* 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

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.