Drug Safety Manager

Responsibilities

Market Product Case Management & Regulatory Submissions

• 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.

Argus Safety Database Expertise & Data Quality

• 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.

Vendor Governance & Operational Oversight

• 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.

Cross-Functional Liaison & Relationship Management

• 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.

Documentation, Compliance & Inspection Readiness

• 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, deviation documentation, CAPAs, and other operational records.
• Ensure documentation demonstrates sponsor oversight and provides a traceable rationale for key case management and submission decisions.
• Support audits, inspections, health authority inquiries, and internal reviews as a case management and submissions subject matter expert.

Team Leadership & Oversight of Junior Staff

• Provide functional oversight, coaching, and day-to-day guidance to junior case processors and other assigned team members.
• Review work for quality, completeness, consistency, and compliance; provide timely feedback and reinforce documented standards.
• Support onboarding, training, knowledge transfer, priority of workload, and development of case processing capabilities.

Project Management, Problem Solving & Conflict Resolution

• Lead or support operational projects, including process improvements/efficiencies, product launches or transitions, vendor changes, system enhancements, data remediation, and compliance initiatives.
• Develop project plans, define deliverables and dependencies, track actions, manage risks and issues, and communicate status to stakeholders.
• Work independently with minimal supervision, prioritize competing demands, and drive activities to completion.
• Use sound judgment and structured problem solving to resolve operational issues and facilitate conflict resolution across functions and vendors.
• Escalate material compliance, quality, timeline, or resource risks with a clear assessment and recommended path forward.

Qualifications

• Clinical or life sciences degree required; RPh, PharmD, BSN, RN, or equivalent preferred.
• Three to five years of drug safety, pharmacovigilance, or clinical safety experience, including marketed product case management and regulatory submissions.
• Experience overseeing PV vendors or outsourced case processing activities.
• Experience leading projects and providing guidance or oversight to junior case processors.