{"id":416537,"url":"https://alion.io/job/amgen-pharmacovigilance-operations-manager","title":"Pharmacovigilance Operations Manager","company":{"id":4775,"name":"Amgen","domain":"amgen.com","url":"https://alion.io/company/amgen","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":336,"ghost_share":0,"stale_share":0.682,"repost_share":0.018,"time_to_fill_p50_days":42,"computed_at":"2026-11-10T06:52:35Z"}},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":14500,"max_usd":42000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":27},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-08-14T00:00:00Z","employer_posted_date":"2026-08-14","last_verified_at":"2026-11-10T05:00:42Z","board_verified":true,"closed_at":null,"days_open":88,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":88},"description":"Career Category\nSafetyJob Description\nThe Pharmacovigilance Operations Manager at Amgen oversees the operations of the pharmacovigilance department, including the handling of adverse event reports, risk management, and safety communication. They ensure compliance with global safety regulations and guidelines.\nJob Summary\nResponsible for:\nSupport ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirements\nProvide vendors with resources and training to perform their role\nSupport the analysis and communication of case QC results\nLead development and delivery of training materials for case management conventions\nSupport resolution of case related specific queries \nManagement of multiple business partner relationships for case management \nSupport reviews of contract wording for case related data exchange\nMonitoring compliance regarding regulatory submissions and/or contractual wording for data exchange\nAssign tasks within Case Management to direct and indirect reports\nSupport management of staff within Case Management\nEscalation of case processing issues\nAudit & external inspection support\nUndertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness\nBe representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility\nPerforms other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor\nKey Activities\nDay-to-day vendor management issues\nInteract with other local safety offices\nEnsure case processing timelines for AE intake, triage and submission are met\nAssess workload to assist in resource management\nSupport on-boarding and on-going training of vendors\nAttend management meetings with vendors\nSupport analysis of QC trends\nSupport generating, communicating, and archiving of reports of QC findings\nSupport audits of CAPAs and other actions/recommendations for ICSR quality related measures\nPerform case review as required\nLead development and delivery of convention-related training material\nSupport training of local office staff \nPerform US case follow up activities\nPerform BP reconciliation as required by safety agreement\nGenerate and distribute performance metrics (submission compliance, volumes, turnaround times)\nSupport reviews of contract wording for case related data exchange\nSupport regulatory inspection and support for vendor audits/inspections\nOversee performance monitoring and relay metrics to vendors\nSupport analysis of QC trends including actions/recommendations\nGenerate, communicate, and archive report of QC findings\nKnowledge and Skills\nUnderstanding of global regulatory requirements for pharmacovigilance\nProject leadership experience\nCompetence in safety systems\nExperience in supporting inspections or internal audits\nMicrosoft Suite: Word, Excel, PowerPoint, Project, Outlook \nEducation & Experience (Basic)\nMaster’s degree and 3 years of directly related experience OR \nBachelor’s degree and 5 years of directly related experience OR \nAssociate’s degree and 10 years of directly related experience OR \nHigh school diploma / GED and 12 years of directly related experience, AND \nPrevious experience directly managing teams, projects, programs or directing the allocation of resources \n.","description_format":"text","description_chars":3411,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)","Prescription Drugs","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-06T03:09:05Z"}],"visa":[],"liveness":{"score":14,"band":"cold","label":"Long shot","p_open":1,"p_active":0.512,"p_room":0.28,"age_days":88,"expected_fill_days":42,"reasons":["conf:1","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-10T06:52:35Z"},"pay":null,"html_url":"https://alion.io/job/amgen-pharmacovigilance-operations-manager","json_url":"https://alion.io/job/amgen-pharmacovigilance-operations-manager.json","meta":{"generated_at":"2026-11-10T09:25:21Z","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":21931,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":4775},"rest":"https://alion.io/mcp/rest/get_company?id=4775"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famgen-pharmacovigilance-operations-manager"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Famgen-pharmacovigilance-operations-manager"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Famgen-pharmacovigilance-operations-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/amgen-pharmacovigilance-operations-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-pharmacovigilance-operations-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":416537}},{"tool":"search_jobs","arguments":{"company":"amgen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":416537},"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. Docs: https://alion.io/developers"}}