Job
Description
As a Medical Safety Expert, your role involves performing medical review of safety reports, triage activities, and signal management activities. You will be responsible for signal detection, validation, prioritization, and assessment, as well as proposing recommendations. Additionally, you will conduct safety evaluation of ongoing signals, safety issues, IRSR, etc. Your tasks will also include reviewing non-ICSR scientific literature from a signal and aggregate report perspective. Key Responsibilities: - Provide safety concerns, search criteria, and literature review for aggregate reports - Conduct medical evaluation of aggregate reports (PSUR, PBRER, PADER, ASR etc.) and analyze the benefit-risk balance of the product - Support the safety writing team with medical expertise - Review Risk Management Plan and participate in risk mitigation activities - Review and approve Individual Case Safety Reports - Provide MedDRA coding - Perform Medical Safety Expert Assessment for regulatory requests - Review safety alerts from regulatory authorities Qualifications Required: - Physician-MBBS/MD professional with a minimum of 5 years of experience in medical review of ICSR - Minimum 2-3 years of experience in signal detection or medical review of safety reports or Risk Management Plan - Proficient in assessing causality, seriousness, labelling, and use of SMQs In this role, you are expected to possess competencies in Developing Talent, Result Orientation, Customer Centricity, Strategic Agility, Process Excellence, Innovation & Creativity, Stakeholder Management, and Collaboration. As a Medical Safety Expert, your role involves performing medical review of safety reports, triage activities, and signal management activities. You will be responsible for signal detection, validation, prioritization, and assessment, as well as proposing recommendations. Additionally, you will conduct safety evaluation of ongoing signals, safety issues, IRSR, etc. Your tasks will also include reviewing non-ICSR scientific literature from a signal and aggregate report perspective. Key Responsibilities: - Provide safety concerns, search criteria, and literature review for aggregate reports - Conduct medical evaluation of aggregate reports (PSUR, PBRER, PADER, ASR etc.) and analyze the benefit-risk balance of the product - Support the safety writing team with medical expertise - Review Risk Management Plan and participate in risk mitigation activities - Review and approve Individual Case Safety Reports - Provide MedDRA coding - Perform Medical Safety Expert Assessment for regulatory requests - Review safety alerts from regulatory authorities Qualifications Required: - Physician-MBBS/MD professional with a minimum of 5 years of experience in medical review of ICSR - Minimum 2-3 years of experience in signal detection or medical review of safety reports or Risk Management Plan - Proficient in assessing causality, seriousness, labelling, and use of SMQs In this role, you are expected to possess competencies in Developing Talent, Result Orientation, Customer Centricity, Strategic Agility, Process Excellence, Innovation & Creativity, Stakeholder Management, and Collaboration.
