Provide medical expertise in the evaluation of safety data as part of the overall pharmacovigilance process, determining the medical and scientific relevance of serious adverse event reports
Job Summary
Provide medical expertise in the evaluation of safety data as part of the overall pharmacovigilance process, determining the medical and scientific relevance of serious adverse event reports.
Serve as a senior technical leader, participating in matrix management activities and preparing aggregate reports in collaboration with other teams.
Perform medical safety review of protocols, Investigator Brochures, and CRFs, and provide aggregate reviews of safety information to maintain oversight of a product’s safety profile.
Matching Summary
Provide medical expertise in the evaluation of safety data as part of the overall pharmacovigilance process, determining the medical and scientific relevance of serious adverse event reports.
Skills & Requirements
Must-have
Medical expertise in safety data evaluation
Pharmacovigilance process
Aggregate safety reports
Surveillance activities for products
Medical review of AEs and ADRs
Therapeutic area guidance
Nice-to-have
Internal consultant to case processing teams
Lead and participate in training activities
Awareness of medical safety-regulatory developments
Support signal detection efforts
Key Requirements
3 years clinical medicine experience
2 years pharma experience
Medical degree from accredited school
Valid medical license
Knowledge of GCP and ICH guidelines
Knowledge of Pharmacovigilance ICSR and Aggregate reports