Job Description
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.
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.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
The annual base salary for this position ranges from $145,000 to $157,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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