12 month contract
£38 per hour via umbrella / £29 per hour PAYE
To provide safety support and expertise with particular focus on medicines for the treatment and prevention of HIV. The key focus is on safety, evaluation and risk-management.
Day-to-day responsibility for monitoring and evaluating safety profiles for allocated products to ensure that optimal decisions are made at all stages of the product lifecycle, which may span late phase clinical development through to established post-marketing use. Depending on the individual product responsibility, the role will include conducting routine pharmacovigilance activities, signal detection/evaluation and authoring of key regulatory documents (e.g. DSURs, EU RMPs and PBRERs). Throughout delivery of the role, you will ensure that all safety documentation is accurate and available to meet global compliance and regulatory requirements.
Detailed responsibilities may include:
• Authors or assists in the production of global Risk Management Plans for designated products, in consultation with senior colleagues
• Contributing to Regulatory benefit-risk assessments
• Assists in the update of investigator brochures.
• Assist in routine signal detection process (knowledge of the CommonWealth Vigilance Workbench would be advantageous), literature review and, in partnership with safety physician, tools for individual case awareness for all products in area of responsibility.
• Performs signal evaluation activities including analysis of safety data and production of accurate and fit for purpose evaluation documents with clear conclusions.
• Assist in authoring periodic regulatory documents (PSURs [PBRERs], DSURs, licence renewal documentation) according to the agreed process and timelines
EDUCATION, KNOWLEDGE AND TECHNICAL EXPERIENCE
• Bachelors, or above, degree in Biomedical or Health Care related speciality
• Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation
• Competent medical/scientific writing skills
• Sound computing skills Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
• Knowledge and experience of the principles of causality assessment and the evaluation of safety signals
• Basic understanding of the HIV therapy area would be an advantage
• Basic knowledge of some other relevant disciplines (e.g. statistics, pharmacoepidemiology)
• Basic knowledge of medical and drug terminology
• Basic understanding of drug development process
• Basic understanding of drug approval process in major countries