Safety Specialist

• Perform end-to-end processing of Individual Case Safety Reports (ICSRs)
• Receive, document, evaluate, and process Adverse Events (AEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs)
• Conduct follow-up with healthcare professionals, patients, and other reporters to obtain complete case information
• Perform medical review activities and reportability assessments
• Support submissions to regulatory authorities and maintain compliance with reporting timelines
• Perform reconciliation activities related to safety cases and reporting
• Assist with preparation and review of aggregate safety reports, including PADERs, PSURs, and DSURs
• Support signal detection and signal management activities
• Collaborate with cross-functional internal teams, external partners, and vendors
• Maintain compliance with company SOPs, pharmacovigilance procedures, FDA regulations, and ICH guidelines
• Support audits, inspections, process improvements, and pharmacovigilance documentation activities

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