Harrow

Associate

• Assess adverse event reports for validity and seriousness, and triage and prioritize them by regulatory reporting timelines
• Process new and follow-up Individual Case Safety Reports (ICSRs), including MedDRA coding and narrative writing
• Engage healthcare professionals and stakeholders to gather additional adverse-event information
• Support expedited 15-day Alert and non-expedited ICSR submissions to the FDA through E2B(R3) electronic submission
• Exchange safety information with licensing and distribution partners and support monthly partner ICSR reconciliations
• Screen literature search results for reportable cases and safety information
• Support aggregate safety report preparation, including PADERs and DSURs, data pulls, line listings, and reconciliation
• Perform quality checks and maintain inspection-ready documentation according to SOPs and work instructions
• Communicate with regulatory authorities, healthcare professionals, and stakeholders on safety-related matters
• Support pharmacovigilance operations as needed
• Collaborate with clinical research, regulatory affairs, Quality, and medical affairs teams
• Work under the general guidance of the Senior Pharmacovigilance Specialist

Explore Pharmacovigilance Associate at Harrow. Review requirements and application details.

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Pharmacovigilance Associate