Pharmacovigilance Associate

The role

The Pharmacovigilance Associate supports medical information inquiries, adverse event reporting, and product quality complaints. This role involves collecting, monitoring, assessing, and tracking safety information to ensure compliance with FDA and global regulatory requirements.

What you will do

• Assess adverse event reports for validity and seriousness and triage them by regulatory reporting timelines
• Process new and follow-up Individual Case Safety Reports in the safety database including MedDRA coding and narrative writing
• Engage with healthcare professionals and stakeholders to gather additional information about adverse events
• Support timely submission of expedited and non-expedited ICSRs to 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 on products
• Support aggregate safety report preparation including data pulls, line listings, and data reconciliation
• Perform quality checks of processed cases to keep documentation inspection-ready
• Facilitate communication with regulatory authorities, healthcare professionals, and stakeholders
• Collaborate with clinical research, regulatory affairs, Quality, and medical affairs departments

Required 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
• Ability to work independently as well as within teams
• Strong organizational and project management skills
• Confidence, professionalism and credibility whilst interacting with customers and third parties
• Understanding of compliance and of quality management systems
• Must be able to travel independently

About the company

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. It is an entrepreneurial company focused on innovation and patient access to affordable medicines.