Manager – Drug Safety and Risk Management

Job Description

Responsible for medical review of safety reports, triage activities and signal management activities

Perform signal detection, signal validation, prioritization and signal assessment and propose recommendation. Perform safety evaluation of ongoing signals, safety issues, IRSR, etc. Review of non-ICSR scientific literatures from signal and aggregate report perspective.

Provide safety concerns, search criteria and literature review for aggregate reports. Perform medical evaluation of aggregate reports (PSUR, PBRER, PADER, ASR etc.,)  and analyze benefit-risk balance of the product. Provide medical support to the safety writing team.

Review of Risk Management Plan and risk mitigation activities.

Medical review and approval of Individual Case Safety Reports, as required. Support triage team for case validation and raising follow up as required. Providing input for MR Post Procedure Quality Check (PPQC)

Providing MedDRA coding.

Medical Safety Expert Assessment for other activities such as regulatory request.

Review of safety alerts received from regulatory authorities.

Work Experience

Physician-MBBS/MD professional only with minimum 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.

Education

Competencies