Safety Specialist

A Safety Specialist job position has opened up at an international contract research organisation providing drug discovery, lifecycle management and laboratory services. With offices in over 45 countries and approximately 13,000 professionals, this company provide innovative ideas behind multiple sectors. This particular position will be based in Cambridge.

The Safety Specialist is responsible for coordinating and performing adverse event data entry, coding and assessment of adverse events, case review, follow up with reporter and/or associated Health Care Professional, tracking of reports, and regulatory reporting activities. The Safety Specialist is also responsible for literature surveillance and aggregate reporting. S/he maintains knowledge and understanding of the company and client-provided SOPs and current FDA regulations. S/he effectively interfaces with project team members, client contacts and adverse event reporters.

Job Responsibilities:

• Work independently to receive and manage adverse event reports and all necessary documentation resulting from inbound or outbound telephone calls and letter or facsimile transfer from a 3rd party (e.g. client). Documentation includes use of departmental Tracker, preparation of AE narratives, as directed by client format, and coding of event terms utilizing MedDRA. Assign preliminary seriousness and labeledness/listedness of event(s). Enter reported information into company-owned or client-provided safety database and perform necessary triage.
• Review cases entered for quality, consistency and accuracy, including review of peer reports.
• Independently review appropriate resources to develop and maintain knowledge of FDA regulations, Good Clinical Practices and company Corporate, divisional and/or client-specific policies and procedures.
• Interact with client personnel to obtain guidance on case-specific questions, to notify of pending regulatory timelines, and maintain open lines of communication.
• Interact with the reviewing physician(s) to discuss medical appropriateness of adverse event cases and confirm seriousness and labeledness/listedness assessments.
• Review literature abstracts and full-text articles for reportable safety events. Identify and extract all relevant information to create an adverse event report.
• Other duties as assigned.

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.