Pharmacovigilance Associate

Harrow

. Assess adverse event reports for validity and seriousness, and triage and prioritize them by regulatory reporting timelines .

Posted 10/26/2026full-timeRemote • New Jersey • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and drug safety, including the assessment of adverse event reports, regulatory submissions, and compliance with quality management systems. Proficient in engaging with healthcare professionals and stakeholders while maintaining inspection-ready documentation.

Highest-signal resume keywords

Pharmacovigilance ExperienceAdverse Event ReportingMedDRA CodingRegulatory SubmissionsProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Adverse Event AssessmentIndividual Case Safety Reports (ICSRs)E2B(R3) Electronic SubmissionAggregate Safety Report PreparationData AnalysisQuality ChecksSOP ComplianceLiterature Search ScreeningNarrative WritingSafety Information Exchange

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationAnalytical Problem-SolvingOrganizational SkillsTeam Collaboration

Industry Keywords

Life SciencesDrug SafetyRegulatory AffairsPharmacovigilance OperationsComplianceQuality Management SystemsHealthcare Professionals EngagementStakeholder CommunicationInspection-Ready DocumentationPADERs and DSURs

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor's degree in Life Sciences or a related field, or equivalent educational background
2–3 years of experience in pharmacovigilance/drug safety, or a related area
Excellent written and verbal skills in English
Excellent analytical and problem-solving approach
Ability to work independently as well as within teams
Strong organizational and project management skills
Confidence, professionalism and credibility when interacting with customers and third parties
Understanding of compliance and quality management systems
Ability to travel independently as a Harrow Eye, LLC representative

Benefits

Comp & perks

Full-time employment
Remote work arrangement
Occasional travel up to 10%
Regular Monday–Friday operations, 9 am–5 pm
Weekend hours may be needed depending upon workload demands