{"id":921537,"url":"https://alion.io/job/beone-medicines-manager-safety-scientist-2","title":"Manager, Safety Scientist","company":{"id":99686,"name":"BeOne Medicines","domain":"beonemedicines.com","url":"https://alion.io/company/beonemedicines","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":20,"ghost_share":0,"stale_share":0.85,"repost_share":0,"time_to_fill_p50_days":41,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":null,"employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Brazil"],"countries":["BR"],"hiring_countries":["BR"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":35000,"max_usd":99000,"period":"year","method":null,"sample_n":4082},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Amazon ECS","optional":true},{"name":"DHCP","optional":true},{"name":"Power BI","optional":true},{"name":"Veeva","optional":true}],"status":"live","first_seen_at":"2026-09-14T00:00:00Z","employer_posted_date":"2026-09-14","last_verified_at":"2026-11-03T10:24:32Z","board_verified":true,"closed_at":null,"days_open":50,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":50},"description":"BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.\nPLEASE SUBMIT ALL RESUMES/CV'S INENGLISHFOR CONSIDERATION\nLanguage Requirement: Fluent English is Required\nPreferred Experience: Pharmaceutical/Biotech Industry\nLocation : Brazil Remote\nGeneral Description:\nThe Manager, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) to conduct signal detection, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders is an important capability for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.\nEssential Functions:\nSignal and Safety Data Evaluation\nSupport the identification, analysis, and evaluation of safety data for signal detection from all applicable sources\nPerform signal detection and signal assessment along with required documentation following BeiGene process\nSupport and propose data acquisition strategy, methodology, and approach for safety evaluations\nSupport analysis of safety data and author safety assessment\nCollaborate with PSLs, scientists, pharmacoepidemiologists, and other cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy\nExecute signal assessment analysis per strategy and assist with the preparation of presentations for Safety Management Team and Company Safety Committee\nSupport the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)\nApply judgment-based decision-making principles to contribute to key scientific/clinical discussions\nApply effective communication skills to lead and facilitate safety team meetings\nCommunicate relevant safety information to core team, business partners, and key stakeholders in a timely manner\nSupport the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator’s Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members\nClinical Trial Support\nSupport the review of safety data and monitor the safety of patients on allocated clinical trials\nSupport the writing and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees\nContribute to safety sections and review aggregate reports, e.g., PBRERs, DSURs, PADERs\nSupport the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members\nSupport the authoring of Storyboards and Briefing Books for HA interactions\nSupport ad-hoc review of the Safety Management Plans\nSupport investigator training\nRisk Assessment, Regulatory Inquiries, and Periodic Reporting\nAssist with analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/Periodic Adverse Experience Report (PAER), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs)\nProvide high quality support for additional evaluation requests from health authorities (e.g., PRAC PSUSA) for assigned compounds\nSupport strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs.\nAssist with integrated Benefit/Risk assessments\nPromote and Advance the Field of Pharmacovigilance\nAny other tasks assigned by manager to assist in departmental activities\nMinimum Requirements - Education and Experience:\nPharmD, RN or PhD/ MS in a medical field or biological science and 2+ years as a Safety (Pharmacovigilance) Scientist.\nOther Experience: \nPharmaceutical product development experience\nExperienced in global regulatory requirements for pharmacovigilance\nSupervisory Responsibilities: \nThe position has no direct reports. The Manager, Safety Scientist is part of a team that performs high quality and timely scientific and operational safety analysis. This position works closely with the Safety Scientist group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations.\nTravel: Less than 10%\nComputer Skills: \nKnowledge working with a safety database (i.e., Argus) for retrieval of safety information\nIntermediate knowledge of MedDRA and signal management system\nAdvanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva)\nFamiliarity with data mining tools and analyses tools such as Spotfire and PowerBI\n#LI-Remote\nGlobal Competencies\nWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.\nFosters Teamwork\nProvides and Solicits Honest and Actionable Feedback\nSelf-Awareness\nActs Inclusively\nDemonstrates Initiative\nEntrepreneurial Mindset\nContinuous Learning\nEmbraces Change\nResults-Oriented\nAnalytical Thinking/Data Analysis\nFinancial Excellence\nCommunicates with Clarity\nWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. 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