Drug Safety Manager

Alkermes

20h•Hybrid

About The Position

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.

Requirements

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.

Responsibilities

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, 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.
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.
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.