Drug Safety Manager

The Drug Safety Manager provides operational leadership and hands-on oversight for end-to-end case management and regulatory submission activities across all marketed products. The role serves as a key liaison among internal case processors, the pharmacovigilance vendor, Medical Information, Medical review team, Product Complaint, Medical Affairs, and other cross-functional partners. The successful candidate will apply strong Argus expertise, sound pharmacovigilance judgment, disciplined documentation practices, and project management skills to ensure compliant, high-quality, and timely safety operations.

The Drug Safety Manager provides operational leadership and hands-on oversight for end-to-end case management and regulatory submission activities across all marketed products. The role serves as a key liaison among internal case processors, the pharmacovigilance vendor, Medical Information, Medical review team, Product Complaint, Medical Affairs, and other cross-functional partners. The successful candidate will apply strong Argus expertise, sound pharmacovigilance judgment, disciplined documentation practices, and project management skills to ensure compliant, high-quality, and timely safety operations.

• Provide end-to-end operational oversight of adverse events and product complaint-linked safety cases for all marketed products, from intake and triage through case closure and regulatory submission.
• Ensure cases are evaluated, coded, documented, quality reviewed, followed up, and submitted in accordance with applicable global regulatory requirements, company procedures, safety data exchange agreements, and established timelines.
• Understand global expedited reporting and submission requirements, including reporting rules, destinations, timelines, acknowledgements, rejections, and resubmission processes.
• Monitor submission status and compliance; investigate late, failed, duplicate, or rejected submissions and drive timely, well-documented resolution.
• Provide subject matter expertise for complex case processing and submission questions and support reconciliation and data-quality activities.

• Demonstrate strong working knowledge of Oracle Argus Safety, including case workflows, data entry conventions, coding, reporting rules, worklists, queries, case locking, and electronic submission outputs.
• Use Argus data, workflow status, audit trail information, and reports to assess case progression, identify gaps, and confirm required actions are complete.
• Partner with safety systems, regulatory, and vendor teams to investigate system or submission issues, document impact, support testing, and verify issue resolution.

• Provide day-to-day oversight of outsourced case processing and submission activities and determine whether vendor deliverables meet regulatory, procedural, quality, and timeline expectations.
• Review vendor outputs, metrics, work queues, compliance trends, quality findings, deviations, and recurring issues; ensure corrective actions are assigned, documented, and completed.
• Maintain clear accountability between sponsor oversight and vendor execution, including effective communication, escalation, and decision-making pathways.
• Build a collaborative working relationship between vendor case processors and internal stakeholders, including Medical Information, Medical review team, Product Complaint, Medical Affairs, Regulatory Affairs, Quality, and Safety Systems.

• Serve as the primary operational liaison between MICC and the broader cross-functional team for safety intake, case processing, follow-up, reconciliation, product complaints, medical information inquiries, and related handoffs.
• Clarify roles, responsibilities, inputs, outputs, and timelines across case processors, medical review team, Product Complaint, Medical Information, and vendor teams.
• Facilitate timely information exchange and resolution of ownership, process, or data discrepancies affecting case quality or reporting compliance.

• Maintain contemporaneous documentation of oversight activities, decisions, issue assessments, escalations, action plans, and closures.
• Author, review, and maintain SOPs, work instructions, process maps, conventions, job aids, meeting minutes, decision logs,…