Remote Pharmacovigilance Associate - Drug Safety

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

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