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Performing medical review of Individual Case Safety Reports (ICSRs); preparation of aggregate reports; performing activities related to signal management for client pharmaceutical products, medical review of narratives for Clinical Study Reports (CSRs), according to client guidelines and Standard Operating Procedures (SOPs) and applicable regulatory requirements
Job Responsibility:
Performing medical review of Individual Case Safety Reports (ICSRs)
preparation of aggregate reports
performing activities related to signal management for client pharmaceutical products
medical review of narratives for Clinical Study Reports (CSRs)
Contributing (authoring and/or medical review) to aggregate reports like Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overview (ACO), Internal Periodic Safety Review (IPSR), Risk Management Plans (RMPs) or other scheduled or unscheduled reports
Medical review of ICSRs for marketed and investigational human and veterinary products
Providing medical advice to PV Scientists to assist them with processing of ICSRs
Drafting Analysis of Similar Events (AOSE) summary for Serious Unexpected Suspected Adverse Reactions (SUSARs)
Signal Management activities including Signal Detection, Validation, Prioritization, Analysis & Assessment
Review of published literature articles/abstracts
Performing additional drug safety related activities, as assigned
Interacting with internal or external contacts to resolve issues related to the assigned work
Identifying any areas of concern within the team and raising these with the Project Manager
Requirements:
MBBS/MD would be preferred
Excellent knowledge of medical terminology
Ability to apply medical judgement, understand, interpret and evaluate data