Pharmacovigilance Associate

Harrow, Inc.; New Jersey; Remote; USD 65,000 - 90,000; Full time

Job summary

Harrow, Inc. in New Jersey seeks a Pharmacovigilance Associate to ensure safety, quality and accuracy of drug products.

You will support medical information inquiries, AE reporting and PQCs via the MICC, with regulatory reporting and ADR management across global requirements. You will triage and code ICSRs, gather additional information from healthcare professionals, and assist with expedited and non-expedited submissions to the FDA, working closely with regulatory, quality and medical affairs

Qualifications

• Bachelor's degree in Life Sciences or related field or equivalent.
• 2-3 years of pharmacovigilance/drug safety experience or related area.
• Excellent written and verbal skills in English.
• Excellent analytical and problem-solving approach.
• Ability to work independently as well as in teams.
• Strong organizational and project management skills.
• Professional and credible interaction with customers and third parties.
• Understanding of compliance and quality management systems.

Responsibilities

• Assess adverse event reports for validity and seriousness and prioritize by regulatory timelines.
• Process new and follow-up ICSRs with MedDRA coding and narrative writing per SOPs.
• Engage with HCPs and stakeholders to gather complete case information.
• Support expedited (15-day) and non-expedited ICSRs submission to FDA via E2B(R3).
• Collaborate with licensing and distribution partners for timely ICSRs reconciliations.
• Screen literature for reportable safety information on Harrow products.
• Support aggregate safety reports like PADERs and DSURs with data pulls and listings.
• Perform quality checks and ensure inspection-ready documentation.
• Communicate safety information with regulators, HCPs and stakeholders to ensure compliance.
• Provide backup support to pharmacovigilance operations and cross-functional teams.

Skills

Excellent written and verbal English

Analytical problem solving

Independent and team work

Organizational and project management

Professional communication with stakeh

Education

Bachelor's degree Life Sciences or equivalent

Job description

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to

Who is Harrow?

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company - where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow's values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world - providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you're the right person to help contribute as we build a truly exceptional company, one we are all so proud of!

Harrow's ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

• A broad Dry Eye Disease product line, led by VEVYE ® and bolstered by well-known adjacent ocular surface disease products such as FLAREX ® and FRESHKOTE ®
• A peri-operative Surgical product line, led by TRIESENCE ® , and BYQLOVI TM
• A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO ® , NATACYN ® , and VERKAZIA ®
• A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

Job Summary

Under the general guidance of the Senior Pharmacovigilance Specialist, the Pharmacovigilance Associate plays a critical role in ensuring the safety, quality, and accuracy of approved drug products by supporting medical information inquiries, adverse event (AE) reporting, and product quality complaints (PQC) through the Medical Information and Communication Center (MICC). This role involves timely regulatory reporting, management of adverse drug reactions (ADRs), and strategic oversight of pharmacovigilance activities, including the collection, monitoring, assessment, evaluation, research, and tracking of safety information. Strong collaboration with internal teams, healthcare professionals, regulatory authorities, and third-party vendors is essential to maintaining high-quality safety communication and compliance with FDA and global regulatory requirements.

• Assess adverse event reports, including those received through product quality complaints or medical information inquiries, for validity and seriousness, and triage and prioritize them by regulatory reporting timelines.
• Process new and follow-up Individual Case Safety Reports (ICSRs) in the safety database in a timely and accurate manner, including MedDRA coding and narrative writing, in accordance with company SOPs and applicable regulatory requirements.
• Proactively engage with healthcare professionals and stakeholders to gather additional information about adverse events, ensuring complete and accurate case information.
• Support timely submission of expedited (15-day Alert) and non-expedited ICSRs to FDA through E2B(R3) electronic submission, in line with 21 CFR 314.80 and Harrow SOPs.
• Exchange safety information with licensing and distribution partners within the timelines in the PVA/SDEA, and support monthly partner ICSR reconciliations.
• Screen literature search results for reportable cases and safety information on Harrow products.
• Support aggregate safety report preparation (e.g., PADERs and DSURs), including data pulls, line listings, and data reconciliation for each reporting period.
• Perform quality checks of processed cases and follow all applicable SOPs and work instructions to keep documentation inspection-ready.
• Facilitate effective communication with regulatory authorities, healthcare professionals, and stakeholders on safety-related matters to foster strong relationships and ensure compliance.
• Provide support to pharmacovigilance operations as needed, demonstrating flexibility and commitment to team goals.
• Collaborate closely with departments like clinical research, regulatory affairs, Quality, and medical affairs to uphold safety standards and regulatory compliance.

Qualifications

• 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
• Demonstrate ability to work independently as well as within teams
• Strong organizational and project management skills
• Demonstrate confidence, professionalism and credibility whilst interacting with customers and third parties
• Demonstrate an understanding of compliance and of quality management systems

Position Type and Expected Hours of Work

This is a full-time (Remote) position in Ledgewood, NJ, with regular operations occurring M-F between 9 am-5pm. Working hours may vary anywhere from several hours before opening to several hours after closing. Additionally, weekend hours may needed depending on workload demands.

Travel

Occasional travel up to 10% is expected for this position. Must be able to travel independently as a Harrow Eye, LLC representative.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Harrow, Inc.'s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.