{"id":2293017,"url":"https://alion.io/job/ucb-safety-specialist","title":"Safety Specialist","company":{"id":1798748,"name":"UCB","domain":"ucb.com","url":"https://alion.io/company/ucb-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Phenom","truth_index":{"grade":"B","score":80,"open_postings":9,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":6,"computed_at":"2026-10-13T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Tokyo, Japan"],"countries":["JP"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-06-23T08:48:58Z","employer_posted_date":"2026-06-23","last_verified_at":"2026-10-13T06:57:29Z","board_verified":true,"closed_at":null,"days_open":112,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":111},"description":"Make your mark for patients\n患者さんのためにあなたの力を発揮してください\n※ご応募の際は英文と日本語文両方のCVが必要になります。\nJOB SUMMARY\nPrimary Purpose / Regulatory Responsibilities:\nResponsible for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the Affiliate as delegated\nBack up (or primary when delegated) contact for pharmacovigilance at the Affiliate\nSupport the operational management of 1-2 medium or 1 highly complex Affiliate/country\nMAJOR RESPONSIBILITIES\nSupport the Local Safety Officer to ensure oversight and management of Affiliate PV responsibilities as delegated/applicable:\nPharmacovigilance System\nImplement and maintain a pharmacovigilance system for the UCB products authorized in the territory and ensure compliance with applicable regulatory and company requirements;\nIdentify and clearly articulate evolving local needs (regulation changes, eco-system changes, etc.) impacting Pharmacovigilance and as required work collaboratively with corporate Pharmacovigilance teams to develop and implement solutions; Provide input to harmonize global/local processes and to secure compliance; Work in close collaboration with corporate Pharmacovigilance teams to ensure that local obligations are managed and compliance to local authorities is maintained and secured;\nMaintain quality management system related to pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed in order to ensure alignment with global SOPs; Maintain oversight of local deliverables delegated to service providers;\nEnsure timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate.\nMaintain a functional connection with the Qualified Person for Pharmacovigilance (Global/EEA QPPV) e.g. participating in regular Local Safety Officer (LSO) meetings organized by corporate Pharmacovigilance;\nEnsure that the required local information for the Pharmacovigilance System Master File (PSMF) is made available to the EEA QPPV office, either directly or through local delegations (UCB colleagues or third parties);\nEnsures that adequate back-up processes are available\nProactive Regulatory Intelligence\nMaintain thorough knowledge of the local current pharmacovigilance regulatory requirements and landscape plus proactively monitor for emerging regulations and communicate such to corporate teams (including EEA QPPV), local stakeholders;\nPerform Impact assessment, gap analysis and implementation strategy for new or updated regulations and notify Global/EEA QPPV (as applicable), corporate Pharmacovigilance and relevant stakeholders.\nHealth Authority inspections and Audit readiness\nEnsure inspection and audit readiness of the relevant local departments in full collaboration with corporate Pharmacovigilance and Quality Assurance;\nParticipate in and manage pharmacovigilance audits and inspections, perform root cause analysis, ensuring timely identification and implementation of respective Corrective Actions Preventive Actions (CAPAs);\nStakeholder Management\nEngage in transversal collaboration with affiliate and corporate stakeholders to secure pharmacovigilance compliance;\nEngage external stakeholders e.g. scientific community, patient advocacy groups, regulators and pharma industry for insights that leads to solutions for patients.\nOther accountabilities for the role may include some or all the tasks, responsibilities such as -\nSupport the LSO in operational management of 1-2 medium or 1 high complexity Affiliate/country.\nCollaborate as Deputy LSO for another country outside of direct Affiliate responsibility or another Affiliate as applicable\nAct as back-up SME for other Affiliates/countries\nSupport effective, smooth management of Partnerships/vendors additionally for at least 1 countries/Affiliates\nEDUCATION & QUALIFICATION\nBachelor's Degree\nOther : HCP based education (such as physician, pharmacist, nurse) or any relevant graduation/experience in medical-scientific area (such as PhD/master in biological sciences or related degree)\nCOMPETENCIES\nSpecific skills\nExpert in pharmacovigilance, with an in-depth expert knowledge of associated regulatory requirements;\nAbility to plan, organize, prioritize, and execute multiple tasks within assigned objectives to meet compliance requirements;\nHave good interpersonal skills, ability to work independently in matrix organizations;\nTeam working and networking promoter;\nQualities of authenticity, resilience and adaptability;\nCommunicates personal views clearly, even if they may be opposed by others;\nBe a Role model, with high level of integrity and honesty, both internally and externally. Ability to inspire peers, stakeholders and others;\nExcellent oral and written communication skills as the position requires to interact across multiple levels and with diverse functions (e.g. commercial, quality, regulatory, legal, medical) within and outside UCB (e.g. regulators, patients, HCP’s, Pharma industry associations);\nExcellent verbal and written communication in English and local language as required (specify any local language skills according to local requirements, if any);\nGood meeting preparation, facilitation skills\nDemonstrated ability to understand, analyze, and summarize scientific and medical information;\nProfessional demeanor, team orientated, self-motivated, and ability to effectively engage with stakeholders;\nProblem solving:\na) Experience and ability to identify risks or issues, propose solutions or alternatives; Ability to identify gaps, perform trend analysis and implement risk mitigation strategy\nb) The Ability to understand and use technology, knowing its limitations and understanding the risks and the precautions that usage requires\n患者さんのために価値を創造し、ご自身の力を発揮する準備ができているとお感じでしたら、ぜひ私たちにご連絡ください。\n会社概要\nUCBは、神経および免疫領域に注力するグローバルなバイオ医薬品企業です。世界中で約8,500人の社員が、患者さんからインスピレーションを受け、科学の力で前進しています。\nUCBで働く魅力\nUCBでは、単に業務をこなすのではなく、価値を創造することを大切にしています。私たちは挑戦を恐れず、協力し合い、革新を追求しながら、患者さんのために成果を出すことを目指しています。\n誰もが尊重され、受け入れられ、最善を尽くせる平等な機会がある、思いやりと支援に満ちた文化が根付いています。\n私たちは常に「その先」を目指し、患者さん、社員、そして地球に対して人間らしさを大切にした価値を提供しています。\nUCBで働くことで、自分自身の成長を実感し、自由にキャリアを築き、可能性を最大限に引き出すことができます。\nUCBでは機会均等を重視しています。すべての採用決定は、法律で保護されているいかなる属性にも関係なく行われます。\n選考プロセスにおいて、ご自身の強みや能力を十分に発揮できるよう配慮が必要な場合は、以下のメールアドレスまでご連絡ください：\n\n※なお、この問い合わせ先では選考における特別な配慮に関するご相談以外はお受けできませんので、ご注意ください。","description_format":"text","description_chars":6542,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"Japanese","level":"Advanced (C1)","optional":false},{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Biologics & Biosimilars"],"lifecycle":[{"event":"open","at":"2026-10-11T19:19:30Z"}],"visa":[],"liveness":{"score":2,"band":"cold","label":"Long shot","p_open":1,"p_active":0.082,"p_room":0.28,"age_days":111,"expected_fill_days":6,"reasons":["conf:2","win:tail","crowd:brand"],"computed_at":"2026-10-13T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/ucb-safety-specialist","json_url":"https://alion.io/job/ucb-safety-specialist.json","meta":{"generated_at":"2026-10-13T10:46:42Z","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":16573,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"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":1798748},"rest":"https://alion.io/mcp/rest/get_company?id=1798748"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fucb-safety-specialist"},{"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%2Fucb-safety-specialist"},{"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%2Fucb-safety-specialist"},{"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/ucb-safety-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fucb-safety-specialist"}]}