Pharmacovigilance Associate

Harrow, Inc.; Oregon; Hybrid; USD 70,000 - 95,000; Full time

Job summary

Harrow, Inc. is seeking a Pharmacovigilance Associate to ensure the safety and quality of approved drugs.

You will support medical information inquiries, AE reporting, and product quality complaints through the MICC, coordinating with regulatory authorities and third-party vendors to maintain safety compliance. Based in a remote full-time role in the United States, you will work with cross-functional teams including clinical research, regulatory, QA, and medical affairs to uphold safety

Qualifications

• Bachelor's degree in Life Sciences or related field is required.
• 2-3 years of pharmacovigilance/drug safety experience.
• Excellent written and verbal English communication skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently and in teams.
• Strong organizational and project management skills.
• Professionalism and credibility with customers and third parties.
• Understanding of compliance and quality management systems.

Responsibilities

• Assess adverse event reports for validity and seriousness and triage by regulatory timelines.
• Process new and follow-up IC S Rs in safety database with MedDRA coding and narratives.
• Engage with healthcare professionals to gather additional information on adverse events.
• Support timely submission of expedited and non-expedited IC SRs.
• Coordinate safety information exchanges with partners within PVA/SDEA timelines.
• Screen literature for reportable safety information on Harrow products.
• Support aggregate safety reporting (e.g., PADERs, DSURs) with data pulls and line listings.
• Perform quality checks on processed cases and maintain inspection-ready documentation.
• Communicate safety-related matters with regulators, healthcare professionals, and stakeholders.
• Assist pharmacovigilance operations as needed and collaborate with clinical, regulatory, QA, and medical affairs teams.

Skills

English proficiency

Analytical thinking

Teamwork

Organizational skills

Communication skills

Education

Bachelor's degree in Life Sciences

Job description

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:

• An expanding Retina Portfolio including IHEEZO®, TRIESENCE®, BYOOVIZTM, and OPUVIZTM
• 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 BYQLOVITM
• 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.

Essential Responsibilities

• 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 IC...
• 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 be needed depending upon workload demands.TravelOccasional travel up to 10% is expected for this position. Must be able to travel independently as a Harrow Eye, LLC representative.