Pharmacovigilance Associate

Job Summary 

Under the general guidance of the Senior Pharmacovigilance Specialist, the Pharmacovigilance Associate plays a critical role in ensuring the safety, quality, and accuracy of approved drug products by supporting medical information inquiries, adverse event (AE) reporting, and product quality complaints (PQC) through the Medical Information and Communication Center (MICC). This role involves timely regulatory reporting, management of adverse drug reactions (ADRs), and strategic oversight of pharmacovigilance activities, including the collection, monitoring, assessment, evaluation, research, and tracking of safety information. Strong collaboration with internal teams, healthcare professionals, regulatory authorities, and third-party vendors is essential to maintaining high-quality safety communication and compliance with FDA and global regulatory requirements. 

 

Essential Responsibilities 

• Assess adverse event reports, including those received through product quality complaints or medical information inquiries, for validity and seriousness, and triage and prioritize them by regulatory reporting timelines. 

• Process new and follow-up Individual Case Safety Reports (ICSRs) in the safety database in a timely and accurate manner, including MedDRA coding and narrative writing, in accordance with company SOPs and applicable regulatory requirements. 

• Proactively engage with healthcare professionals and stakeholders to gather additional information about adverse events, ensuring complete and accurate case information. 

• Support timely submission of expedited (15-day Alert) and non-expedited ICSRs to FDA through E2B(R3) electronic submission, in line with 21 CFR 314.80 and Harrow SOPs. 

• Exchange safety information with licensing and distribution partners within the timelines in the PVA/SDEA, and support monthly partner ICSR reconciliations. 

• Screen literature search results for reportable cases and safety information on Harrow products. 

• Support aggregate safety report preparation (e.g., PADERs and DSURs), including data pulls, line listings, and data reconciliation for each reporting period. 

• Perform quality checks of processed cases and follow all applicable SOPs and work instructions to keep documentation inspection-ready. 

• Facilitate effective communication with regulatory authorities, healthcare professionals, and stakeholders on safety-related matters to foster strong relationships and ensure compliance. 

• Provide support to pharmacovigilance operations as needed, demonstrating flexibility and commitment to team goals. 

• Collaborate closely with departments like clinical research, regulatory affairs, Quality, and medical affairs to uphold safety standards and regulatory compliance. 

 

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  

• Demonstrate ability to work independently as well as within teams 

• Strong organizational and project management skills 

• Demonstrate confidence, professionalism and credibility whilst interacting with customers and third parties 

• Demonstrate an understanding of compliance and of quality management systems 

 

Position Type and Expected Hours of Work 

This is a full-time (Remote) position in Ledgewood, NJ, with regular operations occurring M-F between 9 am-5pm. Working hours may vary anywhere from several hours before opening to several hours after closing. Additionally, weekend hours may be needed depending upon workload demands.  

 

Travel 

Occasional travel up to 10% is expected for this position. Must be able to travel independently as a Harrow Eye, LLC representative.