Drug Safety Scientist

Here is a chance to join one of the most globally known pharmaceutical organisations, who is looking to hire a Drug Safety Scientist based in High Wycombe. This job will be working a top 10 pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries.

Job Responsibilities:

• 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
• May be involved in mentoring/training of company staff and/or third party partners with respect to pharmacovigilance May be involved in completion of periodic reconciliation activities
• May be assigned as key contact for studies or partner contracts
• Support Head of Drug Safety/LSO in responding to ad hoc requests as required
• Report Adverse Events and complaints in a timely way to Drug Safety according to current Adverse Event Reporting guidelines/SOP and to maintain Regulatory Compliance Acts in accordance with company HCC

Skills and Requirements:

• 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
• Registration with official governing bodies e.g. General Medical Council, Royal Society of Pharmacists
• Fluency in the English language required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Becky Eaton on +44 203 8001 292 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.