BeOne Medicines · 1 hour ago
Manager, Safety Scientist
United States
Full-time
Remote
Mid, Senior Level
$128K/yr - $168K/yrBeOne Medicines is a rapidly growing company focused on fighting cancer. The Manager, Safety Scientist will support assigned compounds by conducting signal detection, evaluating safety data, and responding to regulatory inquiries while ensuring compliance with global regulations and internal processes.
Pharmaceuticals
Responsibilities
Support the identification, analysis, and evaluation of safety data for signal detection from all applicable sources
Perform signal detection and signal assessment along with required documentation following BeiGene process
Support and propose data acquisition strategy, methodology, and approach for safety evaluations
Support analysis of safety data and author safety assessment
Collaborate 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
Execute signal assessment analysis per strategy and assist with the preparation of presentations for Safety Management Team and Company Safety Committee
Support 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)
Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions
Apply effective communication skills to lead and facilitate safety team meetings
Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner
Support 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
Support the review of safety data and monitor the safety of patients on allocated clinical trials
Support 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
Contribute to safety sections and review aggregate reports, e.g., PBRERs, DSURs, PADERs
Support 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
Support the authoring of Storyboards and Briefing Books for HA interactions
Support ad-hoc review of the Safety Management Plans
Support investigator training
Assist 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)
Provide high quality support for additional evaluation requests from health authorities (e.g., PRAC PSUSA) for assigned compounds
Support strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs
Assist with integrated Benefit/Risk assessments
Any other tasks assigned by manager to assist in departmental activities
Qualification
Required
Pharmaceutical product development experience
Experienced in global regulatory requirements for pharmacovigilance
Knowledge working with a safety database (i.e., Argus) for retrieval of safety information
Intermediate knowledge of MedDRA and signal management system
Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva)
Familiarity with data mining tools and analyses tools such as Spotfire and PowerBI
Effective communication and influence with internal and external stakeholders
Ability to apply effective prioritization, critical thinking, and judgment-based decision making
Ability to collaborate with PSLs, scientists, pharmacoepidemiologists, and other cross-functional personnel
Ability to support the development, update, and review of safety communication documents
Ability to support the review of safety data and monitor the safety of patients on allocated clinical trials
Ability to contribute to safety sections and review aggregate reports
Ability to support the authoring and review of safety sections of regulatory submissions
Ability to assist with analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports
Ability to support strategy development, analysis, and response to safety questions from health authorities
Ability to assist with integrated Benefit/Risk assessments
Ability to apply judgment-based decision-making principles to contribute to key scientific/clinical discussions
Ability to lead and facilitate safety team meetings
Ability to communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
Founded in 2010
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase