{"id":3460639,"url":"https://alion.io/job/purdue-senior-manager-safety-cluster-lead","title":"Senior Manager, Safety Cluster Lead","company":{"id":1248989,"name":"Purdue","domain":"purdue.ca","url":"https://alion.io/company/purdue-ca","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":9,"ghost_share":0,"stale_share":0.556,"repost_share":0,"time_to_fill_p50_days":46,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Sales","role_family":"Sales","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Sydney, Australia"],"countries":["AU"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-29T13:45:34Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-10-31T06:30:06Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Senior Manager, Safety Cluster Lead\nLocation: Sydney, Australia \nFunction: Global Safety (Pharmacovigilance)\nReporting to: Director, Safety Operations\nAt Mundipharma, you'll have the opportunity to play a critical leadership role in ensuring patient safety and regulatory compliance across our global pharmacovigilance operations. As Senior Manager, Safety Cluster Lead, you will drive the execution, oversight, and continuous improvement of local Pharmacovigilance (PV) operational activities across multiple territories, supporting Mundipharma's vision of a centralized and globally aligned safety organization.\nThis role offers the opportunity to lead critical safety operations, collaborate with global stakeholders, manage key vendor partnerships, and contribute to the ongoing evolution of Mundipharma's global safety systems and processes. If you're passionate about patient safety, operational excellence, and driving global impact within Pharmacovigilance, we'd love to hear from you.\nWhy This Opportunity Stands Out\nGlobal Pharmacovigilance Leadership\nTake ownership of local PV operational oversight across multiple territories while supporting the strategic globalization and centralization of Mundipharma's Pharmacovigilance framework.\nPatient Safety Impact\nPlay a pivotal role in ensuring the timely collection, evaluation, and reporting of safety information that helps protect patients worldwide.\nStrategic Vendor Oversight\nLead oversight of Pharmacovigilance service providers and intake vendors, ensuring quality, compliance, and operational excellence across all PV activities.\nRegulatory & Inspection Readiness\nBe at the forefront of audit and health authority inspection preparedness, helping maintain a culture of quality and compliance throughout the organization.\nCross-Functional Global Collaboration\nPartner with Global Safety Leadership, Quality Assurance, Regulatory Affairs, Clinical Safety, and external stakeholders to ensure seamless execution of safety operations.\nContinuous Improvement & Innovation\nContribute to the transformation and optimization of global safety processes, systems, and operating models to support future growth and efficiency.\nThe Opportunity\nAs Senior Manager, Safety Cluster Lead, you will provide operational leadership for Pharmacovigilance activities across designated territories within the Global Mundipharma organization. You will be responsible for ensuring the effective oversight and delivery of local PV activities, management of external vendors, compliance monitoring, and support of audit and inspection readiness programs.\nWorking closely with Global Safety leadership and regional stakeholders, you will help ensure that all safety operations are executed efficiently, consistently, and in full compliance with applicable regulatory requirements and global procedures.\nKey Responsibilities\nPharmacovigilance Operational Leadership\nProvide leadership and oversight for local Pharmacovigilance operational activities across assigned territories.\nEnsure appropriate implementation and maintenance of safety processes, SOPs, work instructions, and operational documentation.\nContribute to the development and maintenance of Safety Management Plans.\nSupport the execution of global and local PV requirements in alignment with regulatory expectations and company standards.\nDrive execution excellence across all PV operational activities.\nVendor Management & Operational Oversight\nManage and oversee Pharmacovigilance intake vendors responsible for local safety activities.\nEnsure effective delivery of: Individual Case Safety Report (ICSR) management Local literature monitoring Pharmacovigilance training activities Additional local PV operational requirements\nMonitor vendor performance through established KPIs and compliance metrics.\nEnsure quality, accuracy, and timeliness of all safety deliverables.\nEscalate performance concerns and implement corrective actions where necessary.\nCompliance, Inspection & Audit Readiness\nAct as the primary point of contact for Pharmacovigilance operational audits and regulatory inspections.\nPartner closely with Quality Assurance to maintain continuous inspection readiness.\nEnsure CAPA actions are appropriately managed and implemented.\nSupport internal and external audits and contribute to regulatory responses when required.\nPromote a culture of quality and compliance across all safety operations.\nGlobal Safety Collaboration\nServe as an active member of the Global Safety organization.\nCollaborate with Global Case Management, Safety Systems, Safety Evaluation, Safety Compliance, and Clinical Safety teams.\nSupport the achievement of organizational goals and Pharmacovigilance compliance objectives.\nEscalate operational and compliance risks appropriately to the Director, Safety Operations and EEA QPPV.\nEnsure effective communication of key safety operational issues and resolutions.\nProcess Improvement & Operational Excellence\nParticipate in global initiatives aimed at improving safety systems, processes, and operating models.\nIdentify opportunities to optimize workflows, enhance compliance, and improve operational efficiency.\nSupport implementation of process improvements impacting the Global Safety organization.\nContribute to the development of a high-performing, globally integrated PV function.\nWhat We're Looking For\nEssential Qualifications\nBachelor's degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related scientific discipline.\nAdditional qualification or specialization in Pharmacovigilance, Drug Safety, or Regulatory Affairs is highly desirable.\nStrong understanding of international Pharmacovigilance regulations and requirements.\nFluent English communication skills, both written and verbal.\nExperience\nMinimum 3-5 years of experience in Pharmacovigilance.\nPreferably at least 3 years of experience in Pharmacovigilance Operations.\nExperience managing outsourced PV activities and vendor relationships.\nExperience supporting health authority inspections and audits.\nExposure to global Pharmacovigilance environments and multinational operations.\nExperience working within GxP-regulated environments.\nKnowledge & Skills\nStrong knowledge of Good Pharmacovigilance Practice (GVP) requirements.\nRobust understanding of GVP Module VI: Collection, Management and Submission of Reports of Suspected Adverse Reactions.\nSolid understanding of safety case processing and regulatory reporting requirements.\nStrong vendor management and performance monitoring capabilities.\nExcellent problem-solving and decision-making skills.\nStrong project management and organizational abilities.\nExcellent communication and stakeholder management skills.\nAbility to manage multiple priorities in a complex global environment.\nHigh attention to detail and commitment to quality and compliance.\nKey Stakeholder Relationships\nInternal Stakeholders\nVP Safety\nEU QPPV\nDirector, Safety Operations\nDirector, Global Safety Evaluation\nDirector, Safety Compliance & Alliance Management\nDirector, Clinical Safety Evaluation\nDirector, Global Case Management & Safety Systems\nRegulatory Affairs Teams\nQuality Assurance Teams\nMedical Affairs Teams\nExternal Stakeholders\nPharmacovigilance Service Providers\nSafety Intake Vendors\nRegulatory Authorities\nExternal Auditors and Inspectors\nStrategic Safety Partners\nWhat You'll Gain\nAt Mundipharma, you'll join a global organization dedicated to protecting patient safety through innovation, operational excellence, and scientific rigor.\nWe offer:\nCompetitive compensation and benefits package\nOpportunities for global career growth and development\nExposure to international Pharmacovigilance and safety operations\nA collaborative and purpose-driven culture\nMeaningful work that directly impacts patient safety worldwide\nOpportunities to contribute to global transformation initiatives within Safety\nAbout Mundipharma\nMundipharma is a global healthcare company committed to improving the lives of patients through innovation, scientific excellence, and responsible healthcare solutions.\nGuided by our commitment to patient safety, integrity, and continuous improvement, we strive to maintain the highest standards of Pharmacovigilance and regulatory compliance while delivering meaningful value to patients, healthcare professionals, and healthcare systems across the world.\nJoin us and help shape the future of global pharmacovigilance and patient safety. Apply today.\nAdditional Job Description:\nPrimary Location:\nAU SydneyJob Posting Date:\n2026-10-29Job Type:\nPermanent","description_format":"text","description_chars":8530,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Australia","iso":"AU","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","OTC & Consumer Health Products"],"lifecycle":[{"event":"open","at":"2026-10-29T13:45:34Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":46,"reasons":["conf:4","win:early"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/purdue-senior-manager-safety-cluster-lead","json_url":"https://alion.io/job/purdue-senior-manager-safety-cluster-lead.json","meta":{"generated_at":"2026-10-31T16:44:15Z","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":26205,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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":1248989},"rest":"https://alion.io/mcp/rest/get_company?id=1248989"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpurdue-senior-manager-safety-cluster-lead"},{"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%2Fpurdue-senior-manager-safety-cluster-lead"},{"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%2Fpurdue-senior-manager-safety-cluster-lead"},{"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/purdue-senior-manager-safety-cluster-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpurdue-senior-manager-safety-cluster-lead"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3460639}},{"tool":"search_jobs","arguments":{"company":"purdue.ca","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3460639},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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