{"id":3021899,"url":"https://alion.io/job/amgen-sr-associate-global-safety","title":"Sr Associate Global Safety","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":"A","score":86,"open_postings":347,"ghost_share":0,"stale_share":0.571,"repost_share":0.012,"time_to_fill_p50_days":43,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Biotech","role_family":"Biotech","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":["Beijing, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":47000,"max_usd":98000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":543},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-19T00:00:00Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-11-01T03:35:18Z","board_verified":true,"closed_at":null,"days_open":13,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":13},"description":"Career Category\nSafetyJob Description\nGroup Purpose\nThis role demonstrates a good working knowledge of Amgen's policies, procedures and systems and practical understanding of legislation which applies to safety practices locally. Effective operation performance is based on ability to conduct core operational activities based on competent knowledge of safety terminology, database use and tools needed to handle and submit individual and period safety reports. The role also requires the ability to develop a broad understanding of how local safety supports both Amgen Global Patient Safety and the local business.\nJob Summary\nThe major activities for the role are:\nTo conduct core safety activities including data collection, processing, distribution and regulatory submission within the relevant local country/countries, based on appropriate training and assigned roles within the safety database and related systems.\nTo maintain compliance with local legislation and Company policies. To assist Safety Manager to provide full range of safety activities to support the local business, including safety training and participation in local medical teams providing safety expertise and information. The ability to identify, prioritise and escalate safety issues is also very important.\nKey Activities\nCollaborative Activities:\nParticipates in global/ regional/ country safety meetings\nProvides input into Safety or cross functional initiatives, if required, to share and develop best practice Local Safety Affiliate Activities (For local country or countries)\nMaintains own current knowledge of and compliance with local safety regulations for local country or countries\nWorks with Safety Manager to keep local affiliate safety requirements up to date in GRAAS SOPs and manuals, and reporting requirements.\nEnsures that local safety activities are documented and filed or archived in line with Amgen /GRAAS policies and procedures\nAssists in the training on adverse event reporting obligations for local customer-facing staff and others required by national practice or Company policy, also for relevant contractors, agents, business partners or distributors\nAssists local Safety team during conduct of audits & inspections of safety operations and other PV interactions with local Regulators\nAssists Safety Manager and local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors and distributors, as applicable Core Safety Affiliate Operational Responsibilities\nTimely & accurate capture, routing, translation and follow up of adverse events reported in the local country(ries) for inclusion in the Global Safety database\nAssists with timely submission of all reportable adverse event reports\nAssists with distribution of periodic safety reports for local and/or regional needs\nAssists with the dissemination of urgent safety communications, DHPCs and DILs required by Amgen decisions or Regulatory Agency demands, according to local requirements\nAssists in safety screening of local medical literature\nFacilitates exchange of adverse event information with functional service providers, distributors or business partners, in line with specific agreements or procedures\nAssists intake of product complaints in countries where local safety department is designated to support product quality department with this activity.. Compliance Activities:\nWorks with Safety Manager to maintain required standard of local operating performance and reporting compliance for AE case and periodic safety reports\nParticipates in resolution of local issues that occur, through CAPAs and related activities\nEnsures local quality assurance measures to maintain inspection readiness of local safety function\nMay assist Safety Manager and local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors and distributors, as applicable\nMay assist in safety review of protocols of local interventional, non-interventional studies (NIS) and independently sponsored studies to ensure safety monitoring and data collection are appropriately addressed.\nMay assist in local safety review of plans / vendor contracts of local market research studies and patient support programmes to ensure safety contract language, training, monitoring and data collection are appropriately addressed\nMay assist in review of local Amgen sponsored websites/social media projects, if used, to ensure appropriate compliance measures are implemented, for capture of potential adverse events received\nMay assist in tracking dissemination of DHCPS, DILs and risk minimisation measures, such as physician education booklets\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 Therapeutic Area Safety Support\nEscalates product safety issues to local Safety Manager\nDevelops expertise in one or more product or product classes\nMaintains awareness of current prescribing information (eg. SmPC), investigator brochures and risk management plans to support product safety activities Using expertise and with information from Product Safety Teams:\nMay represent Safety in local Medical meetings to discuss product safety issues\nUses specific product expertise to contribute to responses for internal and externally sourced safety questions collaborating with Regulatory or Medical Information, for topics delegated by Safety Manager\nAssists in providing product safety training to commercial or medical colleagues and if applicable, to business partners, contract providers and distributors\nAssists Safety Manager in local implementation of risk minimisation activities associated with approved risk management plans\nAssists Safety Manager to build awareness of product safety issues within local market or clinical research environment and provide feedback to stakeholders as requested by Safety Manager.\nKnowledge and Skills\nGood working knowledge of Amgen's policies, procedures and systems\nPractical understanding of legislation which applies to safety practices locally\nComputer literacy with competent knowledge of database use\nKnowledge of local data privacy requirements\nUnderstanding of relevant medical & safety terminology\nAbility to identify, prioritise and escalate safety issues\nProblem solving abilities\nConfident handling of core operational safety activities, when trained\nEducation & Experience (Basic)\nMaster’s degree\nOR\nBachelor’s degree and 2 years of directly related experience\nOR\nAssociate’s degree and 6 years of directly related experience\nOR\nHigh school diploma / GED and 8 years of directly related experience\nLocation\nBeijing\nEducation & Experience (Preferred)\nProfessional qualification as a health care professional (doctor, pharmacist, nurse, vet ) or doctoral degree\nExperience in biotech/pharma industry - 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