Manager, Safety Scientist at Lifelancer

About this role

Job Title: Manager, Safety Scientist Job Location: Brazil Remote Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: 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. PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION Language Requirement : Fluent English is Required Preferred Experience : Pharmaceutical/Biotech Industry Location : Brazil Remote General Description: The 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. Essential Functions: Signal and Safety Data Evaluation
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, , 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
Clinical Trial Support
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
Risk Assessment, Regulatory Inquiries, and Periodic Reporting
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
Promote and Advance the Field of Any other tasks assigned by manager to assist in departmental activities Minimum Requirements – Education and Experience: PharmD, RN or PhD/ MS in a medical field or biological science and 2+ years as a Safety () Scientist. Other Experience:
Pharmaceutical product development experience
Experienced in global regulatory requirements for
Supervisory : The 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. Travel: Less than 10% Computer Skills:
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
Global Competencies When 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.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
We 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. All employment is decided on the basis of qualifications, merit, and business need. This job is curated by Lifelancer . Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles. Originally posted on Himalayas