|Location: High Wycombe, Buckinghamshire||Salary: Up to £28 per hour|
|Sector: Client Delivery||Type: Temporary|
|Contact: Charlie Ringer||Job Published: 20 days ago|
Drug Safety Scientist needed - High Wycombe - 12 month contract - Up to £28 per hour
Drug Safety Scientist needed for a multinational pharmaceutical organisation based in High Wycombe who are looking to employ an experienced Drug Safety Scientist with strong knowledge and awareness of industry principles of drug development and pharmacology.
The successful Drug Safety Scientist will want to work for this client not just because it's a great opportunity but also because they will receive a pay rate of up to £28 per hour.
Some of the main duties of the Drug Safety Scientist 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
- 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
Required skills for the successful Drug Safety Scientist
- 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 Experience
- Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable
- Degree-level qualification (ideally in life sciences) or equivalent nursing qualification
If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!