Director, Pharmacovigilance Operations

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

📋 Description

• Provide daily management of the company's Pharmacovigilance system and assigned PV activities.

• Supervise global pharmacovigilance operations, including case processing, reporting, literature monitoring, safety data reconciliations, and outsourced PV services.

• Assess safety data for quality, completeness, and consistency across clinical trials.

• Track PV performance metrics, quality indicators, quality trends, and compliance statistics.

• Identify, investigate, and escalate PV compliance concerns.

• Assist in the implementation of new products, partnerships, and business initiatives that impact PV activities.

• Lead oversight of PV vendors, CROs, license partners, patient-support service providers, and other external stakeholders.

• Maintain vendor performance and adherence to contractual/PVA obligations, coordinating governance reviews.

• Organize inspection readiness, regulatory inspections, vendor audits, inspection responses, commitments, and follow-up actions.

• Support the pharmacovigilance quality framework by monitoring deviations, quality events, CAPAs, audits, inspections, and corrective actions.

• Oversee PV training governance and keep PV procedures, work instructions, governance records, and evidence repositories up to date.

• Assist in the development, implementation, and maintenance of Pharmacovigilance Agreements and partner governance documents.

• Act as the operational liaison and PV project manager between Pharmacovigilance and internal stakeholders.

• Facilitate PV governance meetings, coordinate cross-functional safety deliverables and timelines, and present compliance trends, risks, and recommendations to PV leadership.

• Support strategic initiatives and organizational change activities that impact the PV system.

⛳️ Requirements

• Bachelor's degree, ideally in a science or health-related discipline.

• Background in the pharmaceutical industry with proven expertise in pharmacovigilance.

• Demonstrated experience in vendor oversight, PV Agreements, compliance monitoring, inspection readiness, regulatory reporting requirements, quality systems, and CAPA management.

• Familiarity with FDA, ICH, and global pharmacovigilance regulations.

• Experience in supporting FDA inspections.

• At least 10+ years of experience in Drug Safety/PV operations within the biotech sector.

• Experience in specialty pharmaceuticals, biotechnology, or highly outsourced pharmacovigilance settings.

• Extensive knowledge of PV science, operations, and global PV regulations.

• Understanding of PV regulations and compliance, vendor governance, inspection readiness, quality systems, risk management, PV agreements, compliance metrics, and oversight.

• Strong analytical, communication, organizational, and project management abilities.

🏝️ Benefits

• Flexibility to work from home.

• Hybrid or remote work options based on location.

• Travel as needed for business purposes.