Pharmacovigilance Manager

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 click this link and get to know us.

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^®, BYOOVIZ^TM, and OPUVIZ^TM
• 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 Director of Quality, Compliance, and Pharmacovigilance, the Pharmacovigilance Manager plays a crucial role in ensuring the safety, quality, and accuracy of Harrow’s Approved Drug products. Some of the key functions include the operational and surveillance pharmacovigilance activities, including but not limited to the collection of adverse events from various sources, assessment and reporting of individual case safety reports (ICSRs), signal detection, and compilation of aggregated safety reports. You will also lead continuous improvement efforts and maintain Pharmacovigilance activities with both External and internal Parties.

Essential Responsibilities

• Lead and oversee local pharmacovigilance activities in compliance with global and local regulatory requirements, company policies, and Standard Operating Procedures (SOPs)
• Act as the local pharmacovigilance lead, ensuring effective implementation of the Pharmacovigilance System and alignment with global safety governance
• Manage and oversee the collection, assessment, processing, and reporting of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and Product Quality Complaints (PQCs)
• Lead signal management activities, including signal detection, validation, prioritization, assessment, documentation, escalation, and tracking in accordance with regulatory requirements and internal procedures
• Ensure timely identification and escalation of safety signals, emerging safety concerns, and benefit–risk issues to Global Safety, QPPV, and relevant governance bodies
• Lead the preparation, review, and maintenance of Pharmacovigilance Agreements (PVAs) with partners, distributors, licensors, CROs, and other third parties, ensuring clear allocation of PV responsibilities and regulatory compliance
• Act as the primary PV contact for third parties, ensuring effective communication, compliance with contractual obligations, and oversight of partner PV performance
• Establish, implement, and continuously improve processes, procedures, and training programs for the handling of medical inquiries, including AEs, PQCs, and medical information requests
• Oversee accurate data entry, quality review, and compliance monitoring of safety and PQC cases in the Global Safety Database, ensuring adherence to regulatory reporting timelines
• Ensure appropriate triage, investigation, documentation, and follow-up of PQCs, including assessment of potential safety impact and coordination with Quality, Manufacturing, and Global Safety teams
• Oversee follow-up activities with reporters (healthcare professionals, patients, and company representatives) to ensure completeness and high-quality safety data
• Ensure consistent application of AE, SAE, SUSAR, PQC, and signal management criteria, and ensure timely submission and escalation of reportable cases to Head Office and Regulatory Authorities
• Maintain inspection readiness; lead or support regulatory inspections and audits, and manage CAPAs related to pharmacovigilance and quality findings
• Contribute to the development, maintenance, and continuous improvement of local and global PV systems, procedures, and documentation
• Provide leadership, mentoring, and performance oversight to PV staff, ensuring appropriate training, competency development, and workload management
• Act as a key local PV contact, supporting cross-functional collaboration with Medical, Quality, Regulatory, Commercial, and Legal teams
• Support broader pharmacovigilance and quality operations as required

Qualifications

• Pharm-D, MD, and RPN or educational equivalent.
• Around 5 years of prior relevant experience, including experience managing clinical trial safety/post-marketing safety, or equivalent combination of education, training, and experience.
• Excellent written and verbal skills in English
• In-depth knowledge of applicable global, regional, and local regulatory requirements, and International Conference on Harmonization (ICH) guidelines.
• Excellent analytical and problem-solving approach when interpreting safety reports, literatur,e and undergoing inspections
• Demonstrate ability to work independently as well as within teams
• Strong organizational and project management skills
• Demonstrate confidence, professionalis,m and credibility whilst interacting with customers and third parties
• Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product
• Demonstrate an understanding of compliance and of quality management systems