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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 of the Job:

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, 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

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 Pharmacovigilance

• Any other tasks assigned by manager to assist in departmental activities

Supervisory Responsibilities:

• 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.

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

Other Qualifications:

• Pharmaceutical product development experience

• Experienced in global regulatory requirements for pharmacovigilance

Travel: Less than 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.