{"id":3198663,"url":"https://alion.io/job/alkermes-drug-safety-manager","title":"Drug Safety Manager","company":{"id":1780712,"name":"Alkermes","domain":"alkermes.com","url":"https://alion.io/company/alkermes","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":145000,"max":157000,"currency":"USD","period":"year","gross":null,"usd_annual":157000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Oracle","optional":false}],"status":"live","first_seen_at":"2026-10-08T20:16:13Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-24T20:55:05Z","board_verified":true,"closed_at":null,"days_open":16,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":16},"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.\n Market Product Case Management & Regulatory Submissions\nProvide 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.\nEnsure 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.\nUnderstand global expedited reporting and submission requirements, including reporting rules, destinations, timelines, acknowledgements, rejections, and resubmission processes.\nMonitor submission status and compliance; investigate late, failed, duplicate, or rejected submissions and drive timely, well-documented resolution.\nProvide subject matter expertise for complex case processing and submission questions and support reconciliation and data-quality activities.\nArgus Safety Database Expertise & Data Quality\nDemonstrate strong working knowledge of Oracle Argus Safety, including case workflows, data entry conventions, coding, reporting rules, worklists, queries, case locking, and electronic submission outputs.\nUse Argus data, workflow status, audit trail information, and reports to assess case progression, identify gaps, and confirm required actions are complete.\nPartner with safety systems, regulatory, and vendor teams to investigate system or submission issues, document impact, support testing, and verify issue resolution.\nVendor Governance & Operational Oversight\nProvide day-to-day oversight of outsourced case processing and submission activities and determine whether vendor deliverables meet regulatory, procedural, quality, and timeline expectations.\nReview vendor outputs, metrics, work queues, compliance trends, quality findings, deviations, and recurring issues; ensure corrective actions are assigned, documented, and completed.\nMaintain clear accountability between sponsor oversight and vendor execution, including effective communication, escalation, and decision-making pathways.\nBuild 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.\nCross-Functional Liaison & Relationship Management\nServe 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.\nClarify roles, responsibilities, inputs, outputs, and timelines across case processors, medical review team, Product Complaint, Medical Information, and vendor teams.\nFacilitate timely information exchange and resolution of ownership, process, or data discrepancies affecting case quality or reporting compliance.\nDocumentation, Compliance & Inspection Readiness\nMaintain contemporaneous documentation of oversight activities, decisions, issue assessments, escalations, action plans, and closures.\nAuthor, review, and maintain SOPs, work instructions, process maps, conventions, job aids, meeting minutes, decision logs, deviation documentation, CAPAs, and other operational records.\nEnsure documentation demonstrates sponsor oversight and provides a traceable rationale for key case management and submission decisions.\nSupport audits, inspections, health authority inquiries, and internal reviews as a case management and submissions subject matter expert.\nTeam Leadership & Oversight of Junior Staff\nProvide functional oversight, coaching, and day-to-day guidance to junior case processors and other assigned team members.\nReview work for quality, completeness, consistency, and compliance; provide timely feedback and reinforce documented standards.\nSupport onboarding, training, knowledge transfer, priority of workload, and development of case processing capabilities.\nProject Management, Problem Solving & Conflict Resolution\nLead or support operational projects, including process improvements/efficiencies, product launches or transitions, vendor changes, system enhancements, data remediation, and compliance initiatives.\nDevelop project plans, define deliverables and dependencies, track actions, manage risks and issues, and communicate status to stakeholders.\nWork independently with minimal supervision, prioritize competing demands, and drive activities to completion.\nUse sound judgment and structured problem solving to resolve operational issues and facilitate conflict resolution across functions and vendors.\nEscalate material compliance, quality, timeline, or resource risks with a clear assessment and recommended path forward.\nClinical or life sciences degree required; RPh, PharmD, BSN, RN, or equivalent preferred.\nThree to five years of drug safety, pharmacovigilance, or clinical safety experience, including marketed product case management and regulatory submissions.\nExperience overseeing PV vendors or outsourced case processing activities.\nExperience leading projects and providing guidance or oversight to junior case processors.\nAlkermes 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.\nThe 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","description_format":"text","description_chars":6572,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Hybrid work"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Biologics & Biosimilars","Psychiatric Care"],"lifecycle":[{"event":"open","at":"2026-10-24T06:46:48Z"}],"visa":[],"liveness":{"score":53,"band":"ok","label":"Likely open","p_open":1,"p_active":0.711,"p_room":0.75,"age_days":16,"expected_fill_days":19,"reasons":["conf:8","win:late"],"computed_at":"2026-10-25T05:24:38Z"},"pay":{"stated_usd_annual":157000,"is_top_pay":false},"html_url":"https://alion.io/job/alkermes-drug-safety-manager","json_url":"https://alion.io/job/alkermes-drug-safety-manager.json","meta":{"generated_at":"2026-10-25T05:24:38Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":7397,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1780712},"rest":"https://alion.io/mcp/rest/get_company?id=1780712"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Falkermes-drug-safety-manager"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Falkermes-drug-safety-manager"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Falkermes-drug-safety-manager"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/alkermes-drug-safety-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Falkermes-drug-safety-manager"}]}