Pharmacovigilance Manager

Harrow, Inc.

12d

About The Position

Under the general guidance of the Director of Quality, Compliance, and Pharmacovigilance, the Pharmacovigilance Manager plays a crucial role in ensuring the safety, quality, and accuracy of Harrow’s Approved Drug products. Some of the key functions include the operational and surveillance pharmacovigilance activities, including but not limited to the collection of adverse events from various sources, assessment and reporting of individual case safety reports (ICSRs), signal detection, and compilation of aggregated safety reports. You will also lead continuous improvement efforts and maintain Pharmacovigilance activities with both External and internal Parties.

Requirements

Pharm-D, MD, and RPN or educational equivalent.
Around 5 years of prior relevant experience, including experience managing clinical trial safety/post-marketing safety, or equivalent combination of education, training, and experience.
Excellent written and verbal skills in English
In-depth knowledge of applicable global, regional, and local regulatory requirements, and International Conference on Harmonization (ICH) guidelines.
Excellent analytical and problem-solving approach when interpreting safety reports, literatur,e and undergoing inspections
Demonstrate ability to work independently as well as within teams
Strong organizational and project management skills
Demonstrate confidence, professionalis,m and credibility whilst interacting with customers and third parties
Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product
Demonstrate an understanding of compliance and of quality management systems

Responsibilities

Lead and oversee local pharmacovigilance activities in compliance with global and local regulatory requirements, company policies, and Standard Operating Procedures (SOPs)
Act as the local pharmacovigilance lead, ensuring effective implementation of the Pharmacovigilance System and alignment with global safety governance
Manage and oversee the collection, assessment, processing, and reporting of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and Product Quality Complaints (PQCs)
Lead signal management activities, including signal detection, validation, prioritization, assessment, documentation, escalation, and tracking in accordance with regulatory requirements and internal procedures
Ensure timely identification and escalation of safety signals, emerging safety concerns, and benefit–risk issues to Global Safety, QPPV, and relevant governance bodies
Lead the preparation, review, and maintenance of Pharmacovigilance Agreements (PVAs) with partners, distributors, licensors, CROs, and other third parties, ensuring clear allocation of PV responsibilities and regulatory compliance
Act as the primary PV contact for third parties, ensuring effective communication, compliance with contractual obligations, and oversight of partner PV performance
Establish, implement, and continuously improve processes, procedures, and training programs for the handling of medical inquiries, including AEs, PQCs, and medical information requests
Oversee accurate data entry, quality review, and compliance monitoring of safety and PQC cases in the Global Safety Database, ensuring adherence to regulatory reporting timelines
Ensure appropriate triage, investigation, documentation, and follow-up of PQCs, including assessment of potential safety impact and coordination with Quality, Manufacturing, and Global Safety teams
Oversee follow-up activities with reporters (healthcare professionals, patients, and company representatives) to ensure completeness and high-quality safety data
Ensure consistent application of AE, SAE, SUSAR, PQC, and signal management criteria, and ensure timely submission and escalation of reportable cases to Head Office and Regulatory Authorities
Maintain inspection readiness; lead or support regulatory inspections and audits, and manage CAPAs related to pharmacovigilance and quality findings
Contribute to the development, maintenance, and continuous improvement of local and global PV systems, procedures, and documentation
Provide leadership, mentoring, and performance oversight to PV staff, ensuring appropriate training, competency development, and workload management
Act as a key local PV contact, supporting cross-functional collaboration with Medical, Quality, Regulatory, Commercial, and Legal teams
Support broader pharmacovigilance and quality operations as required