Pharmacovigilance Associate

Job not on LinkedIn

🕒 October 26

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 18 days.
• No salary listed.

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Harrow

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

🏭 Manufacturing

💰 $100M Post-IPO Debt on 2023-03

Pharmaceuticals • Healthcare • Manufacturing

Harrow is a growing leader in the ophthalmic healthcare market, dedicated to innovation and providing affordable and accessible medications. The company closely listens to the needs of providers and their patients, aiming to deliver high-quality products and services. With a remarkable 72% compound annual growth rate over its first eight years, Harrow stands out as one of the fastest-growing ophthalmic pharmaceutical companies in the United States.

📋 Description

• 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

• 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

• 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

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