Senior Drug Safety Specialist
Location: England, Uxbridge
Salary: Excellent rate + benefits
Job Summary:
Working for an international CRO, the Senior Drug Safety Specialist will be the project lead and provide technical and process-related expertise to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Accountabilities/Responsibilities:
-- Lead and manage projects including the development of project specific safety reporting procedures and workflows and provide guidance to the team on the procedures
-- Adverse event (AE) and drug coding
-- Provision of line listings and tabulations for safety reports i.e. periodic safety reports, ad hoc safety reports etc
-- Regulatory authority reporting (electronic and hard copy)
-- Literature reviews
-- Quality Assurance activities such as being the project lead / coordinator for audits and the development of templates, checklists and guidelines
-- Delegate work as appropriate to Drug Safety Specialists, Drug Safety Associates and Drug Safety Assistants
-- Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as CRFs, endpoint packages, review and follow-up patient eligibility for inclusion / exclusion in clinical trials, review protocol violations
-- Delegate work as appropriate to Drug Safety Specialists, Drug Safety Associates and Drug Safety Assistants
Essential Skills & Capabilities:
-- Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification
-- Associates/diploma degree in any of the above with appropriate work experience
-- Fluent English
-- 3-4 years experience in working in drug development and/or healthcare environment


- PHARMACOVIGILANCE

- England