{"id":2083833,"url":"https://alion.io/job/roche-safety-scientist","title":"Safety Scientist","company":{"id":13531,"name":"Roche","domain":"roche.com","url":"https://alion.io/company/roche","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":197,"ghost_share":0.015,"stale_share":0.599,"repost_share":0.071,"time_to_fill_p50_days":15,"computed_at":"2026-10-10T05:45:15Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"middle","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","Shanghai, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":19000,"max_usd":45000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":661},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false}],"status":"live","first_seen_at":"2026-10-08T11:21:04Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-10T23:25:08Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.\nThe Position\nUnder the matrix leadership of the Safety Strategy Leader (SSL) and in collaboration with Portfolio Clinical Safety (PCS) colleagues to:\nDevelop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)\nResponsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)\nResponsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests\nContribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy\nContributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including the IB), risk communications, RMP, REMS\nContributing to study management from a safety perspective through SMT/PET activities and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS\nContribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SPL\nResponsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB\nParticipate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable\nIn partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed.\nAuthor or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals\nActs independently to manage safety responsibilities on study teams and in activities supporting safety science\nTake on the responsibility for specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.\n(Responsibilities due to medical qualifications)\nThey will provide clinical medical expertise and decision-making, in areas where this is specifically required to support colleagues in PCS. Situations where qualified clinical medical input may typically be sought could include, but are not limited to:\nInterpretation of emerging safety-relevant data, in the context of experience gained whilst practising in relevant areas of clinical medicine/healthcare.\nDefining types of safety question or safety issue, in the context of a molecule/program, that may require specific clinical medical safety assessments or decisions to be made.\nPerforming medical practice impact assessments in the context of product quality safety issues (e.g. as part of defined activities outlined in PT-managed processes that require formal assessment by medically qualified individuals).\nDetermining the potential clinical medical impact of non-clinical safety findings, and/or the interpretation of potential product risks associated with such findings, in the context of current external clinical practice.\nProviding advice and interpretation of whether/how risks may impact the overall clinical risk-benefit balance of an asset, in the context of typical clinical medical practice in the territories/countries where the product/asset will be used.\nMaking formal company medical assessments that may be required from PDS, with regard to the suspected causal relationship between reported events and treatment. For example, where this is required in the context of the management of Individual Case Safety Reports (ICSRs) requiring assessment.\nReview of clinical study development plans and/or study protocols (and other relevant clinical trial documentation), to ensure their design is appropriate to current clinical medical practice. In addition, to ensure that the measures outlined in plans/protocols to manage defined patient risks, are appropriate/feasible to implement in the context of current clinical medical practice, and can reasonably be expected to achieve the clinical risk management aims that have been described in relevant risk management plans.\nBehaviours and responsibilities \nDemonstrates independence and high competence in the conduct of all safety science responsibilities\nActively emulate and role model the Roche values, culture (mindset and behavior), Roche core competencies and PD/PDS strategy and drive for similar performance across relevant team\nDemonstrates behaviors consistent with Roche values and engenders confidence from senior management\nDevelop and maintain knowledge of the pharmaceutical industry and drug development, including a comprehensive knowledge of pharmacovigilance activities and requirements\nEnsure all actions are conducted in alignment with Roche quality management systems\nUnderstands how safety activities contribute to company development and commercialisation goals and takes measures to maximize safety value to the organization\nEstablish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams\nConsistently comply with all governing laws, regulations, Roche standard operating procedures (SOPs) and other guidelines\nResponsible for coordination and collaboration with vendors servicing Safety Science\nActs independently and with minimal supervision to manage safety responsibilities on study teams and in activities supporting safety science\nTrains and mentors more junior PCS scientists\nProactively takes on responsibility for more complex deliverables\nTakes on team leadership responsibility in order to manage and complete medium and high priority projects\nSeen by peers and cross-functional colleagues as expert in some safety science activities\nUnder certain conditions, may take on the role of “Safety Strategy Lead (SSL)” for one or more assigned molecules. The SSL is the lead safety accountable for the molecule safety strategy.\nWilling to challenge embedded behaviors/mindsets, in order to bring new and agile approaches to ways of working, and/or to improve quality and efficiency.\nHolds themselves and peers accountable for their behaviours and actions.\nEducation, Skills and Experience \nMinimum:\n- Formal medical qualifications (e.g. MD; MB BS; MB ChB) and have post-graduate experience in one or more areas of clinical medical practice including in medical specialities/disciplines that are relevant to clinical safety and/or to the therapy/disease areas in which the company develops and markets medicines.\nOr:\n- Qualified healthcare professional or Life Sciences graduate.\nPreferred:\nThey will preferably hold relevant Board Certification(s) or be board eligible, and/or other relevant post-graduate medical qualifications, in relevant areas of clinical medicine.\nThey will typically possess 4 or more years of clinical drug development experience in the biopharmaceutical industry or a related sector (e.g. academia; CRO; etc). Preferably including at least 2 years of experience in a clinical drug safety-related role.\nUnderstanding of GxP and regulated processes and end to end clinical trial lifecycle\nStrong orientation towards process improvement and cross-functional teamwork\nEffectively work with remote partners on a global team\nExcellent communication skills, both written and verbal\nApply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity\nStrong presentation skills, effective at summarizing and presenting the key considerations and decision points\nAbility to effectively train others on departmental practices and processes\nApplication of project management methodology\nFluent in Mandarin and English\nWho we are\nA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.\nLet’s build a healthier future, together.\nRoche is an Equal Opportunity Employer.","description_format":"text","description_chars":9472,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":true}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Artificial Intelligence","Biotechnology","Health Care","Biologics & Biosimilars"],"lifecycle":[{"event":"open","at":"2026-10-08T11:21:04Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":1,"expected_fill_days":15,"reasons":["conf:3","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-10T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/roche-safety-scientist","json_url":"https://alion.io/job/roche-safety-scientist.json","meta":{"generated_at":"2026-10-11T03:59:53Z","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","counted_by":"address","units_charged":1,"used_today":2238,"day_limit":5000,"remaining_today":2762,"minute_limit":60,"resets_at":"2026-10-12T00:00:00Z"}},"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":13531},"rest":"https://alion.io/mcp/rest/get_company?id=13531"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Froche-safety-scientist"},{"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%2Froche-safety-scientist"},{"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%2Froche-safety-scientist"},{"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/roche-safety-scientist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Froche-safety-scientist"}]}