Safety Evaluation Scientist

A leading pharmaceutical client is searching for a Safety Evaluation Scientist to join their team in Hatfield, UK. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

This Safety Evaluation Scientist role will act as therapeutic specialist and provide scientific review and input to the preparation of aggregated safety reports and safety evaluations. Also to provide continued safety monitoring of assigned products and provide scientific and operational support to clinical development program(s).

Job Responsibilities:

• To have PV scientific responsibility for assigned products (investigational and post marketing) and to act as a PV expert, providing advice and expertise to others
• To undertake routine signal detection and evaluation activities in conjunction with the GSOs, including the review of literature
• To have major involvement in the production of PSURs, DSURs and risk management plans and in the creation of 6MLL
• To contribute to investigator brochures and protocols, where required
• To work in collaboration with the GSOs and assist with producing accurate responses to safety related questions arising from regulatory authorities, DSMBs and ethics committees
• Build effective working relationships and participate as a member of cross functional project related teams
• Uses appropriate sources of information to prepare Business Objects searches to retrieve relevant data and listings for aggregated Safety Reports and ad hoc safety requests
• To play an active role in helping to strengthen PV operations including in cross functional project related activities
• To contribute to process improvements and prepares and reviews SOP's and Working Practices, as required
• To undertake other activities and projects as required by manager

Skills and Requirements:

• The candidate should be a life science or nursing graduate with proven success in a Global / European Pharmacovigilance department.
• Experience of preparing aggregate safety reports would be beneficial
• Knowledge of PV legislation and principles of both product safety and clinical trial methodology
• Experience with global safety databases and MedDRA coding
• Prior experience of ARISg would be an advantage
• Experience in the clinical analysis and interpretation of data and previous involvement, in the creation of written documents evaluating safety issues, or answering regulatory questions is desirable
• Prior experience of working in oncology would be helpful
• Possess a strong sense of responsibility and have a good track record of working independently and meeting strict deadlines
• Flexibility, adaptability and pro-activity are key requirements for the position.
• Able to adjust behaviour and priorities in a changing environment
• Excellent communications skills (oral and written)
• Good judgement
• Problem solving abilities
• Team player
• Able to form strong cross-functional relationships and influence others.
• Attention to detail
• Organised
• Diplomatic

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 Divya Mistry on+44 203 814 1315 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.

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