Drug Safety Scientist - High Wycombe
Lucy Stendall at CK Group is recruiting for a Drug Safety Scientist to join a company in the Pharmaceutical industry at their site based in High Wycombe on a 12 month contract basis.
The Company: Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies - the largest diversified healthcare group in the world with over 100 years of scientific heritage. They employ approximately 500 people in the UK and Ireland. They are committed to delivering great medicines and have introduced a range of innovative treatments that can make an important difference to the lives of patients with serious health conditions such as schizophrenia, hepatitis C, multiple myeloma, HIV/AIDS and diabetes.
The Location: Working at their Headquarters in High Wycombe, the site is easily commutable. The nearest station is approximately 10 minutes by taxi. If you're travelling by car you can access the site via the M40.
The Role: Responsible for supporting the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs) and /or study sponsor, as applicable.
Key duties 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.
- 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.
Your Background: To be considered for the role you should have the following skills, knowledge and experience:
- Degree-level qualification (ideally in life science) or equivalent qualification.
- Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable.
- 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.
For more information or to apply for this position, please contact Lucy Stendall on 01246 457733 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. 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 44974 in all correspondence.