Drug Safety Lead

• Responsible for medical review of ICSRs for accuracy, medical relevance, and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement.
• Evaluate adverse event report for seriousness, listedness/expectedness, corrects coding of the adverse event and ensures that all medically relevant information from the source documents is included, checks/corrects ranking of events, and provide causality assessment.
• Confirm and rectify coding of terms in other fields such as medical history, lab details or indications.
• Provide medical sign off on the case.
• Ensure appropriate follow-up questions/questionnaires are sent out based on the case.
• Track inconsistencies on activities performed by data entry and QC reviewer and provide feedback to QC team as learnings activities as per client requirement and agreed standards.

Must have:

• Qualification : MBBS is mandatory
• Cognitive abilities including verbal reasoning, attention to detail, critical thinking, scientific accuracy, and analytical ability.
• Good comprehension skills.
• Good communication and interpersonal skills.
• Drive quality and ensure team meets deadlines and commitments.
• Excellent mentoring and training skills.
• Knowledge of disease pathology and physiology, pharmacology, and therapeutics.
• Familiarity with pharmaceutical industry principles of drug development and Pharmacovigilance is preferred but not required.
• Understanding of medical terminology and ability to summarize medical information
• Ability to critically evaluate medical data.
• Ability to accurately and medically present case data, both verbally and in writing.
• Ability to identify, prioritize and assign tasks.
• Consistently exercise good judgment within policies and regulations