Senior Manager, Risk Management (RM), PVE-MSS Cambridge 18 month contract 37.5 hours per week Job Code: JB118211

Responsibilities:
Signal detection and authorship of signal work-up documents in collaboration with a Medical Safety Science Medical Evaluation (MSS-ME) team member Authorship of Company Core Data Sheet (CCDS) sections and associated supporting documentation Authorship of aggregate safety reports (e.g. PSURs) Authorship of risk management plans Authorship of responses to regulatory agency safety enquiries Contributes to safety analyses in Regulatory submissions (e.g., Marketing Authorisation Application (MAAs), New Drug Application (NDAs)) Reviews global literature for identification of potential safety concerns Performs safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies Reviews standard reference documents in collaboration with a MSS-ME team member Requirements: Moderate level (4 years) of experience in drug safety is preferred Demonstrates good project management skills, excellent attention to detail Demonstrates ability to assess complex data sets and understand the safety/medical implications Possesses good knowledge of pharmacovigilance, regulations, aggregate safety reports, risk management plans, signal detection, clinical trials, and clinical development Contact: Please click the 'apply' button to be considered, alternatively please email me directly with a copy of your CV to quoting the job code JB118211 This job was originally posted as www.totaljobs.com/job/86476118