Pharmacovigilance Associate

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Evaluate adverse event reports for validity and seriousness, prioritizing them based on regulatory reporting timelines.

• Manage new and follow-up Individual Case Safety Reports (ICSRs), including MedDRA coding and narrative development.

• Collaborate with healthcare professionals and stakeholders to obtain additional information regarding adverse events.

• Assist in the timely submission of expedited 15-day Alerts and non-expedited ICSR submissions to the FDA via E2B(R3) electronic submission.

• Share safety information with licensing and distribution partners and aid in monthly ICSR reconciliations with partners.

• Review literature search results for reportable cases and safety data.

• Contribute to the preparation of aggregate safety reports, such as PADERs and DSURs, including data extraction, line listings, and reconciliations.

• Conduct quality checks and ensure inspection-ready documentation in accordance with SOPs and work instructions.

• Liaise with regulatory authorities, healthcare professionals, and stakeholders regarding safety-related issues.

• Provide support for pharmacovigilance operations as necessary.

• Work collaboratively with clinical research, regulatory affairs, Quality, and medical affairs teams.

• Operate under the general direction of the Senior Pharmacovigilance Specialist.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a related discipline, or an equivalent educational background.

• 2–3 years of experience in pharmacovigilance/drug safety, or a similar field.

• Exceptional written and verbal communication skills in English.

• Strong analytical and problem-solving abilities.

• Capability to work independently as well as collaboratively within teams.

• Robust organizational and project management skills.

• Professionalism, confidence, and credibility while interacting with clients and third parties.

• Knowledge of compliance and quality management systems.

• Willingness to travel independently as a representative of Harrow Eye, LLC.

🏝️ Benefits

• Full-time employment.

• Remote work flexibility.

• Occasional travel, up to 10%.

• Standard Monday–Friday work schedule from 9 am–5 pm.

• Availability for weekend hours may be required based on workload demands.