Remote Pharmacovigilance Associate — Drug Safety Expert

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

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