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Company

BeiGene · 4 hours ago

Associate Director, Safety Scientist

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$150K/yr - $200K/yr

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BiotechnologyHealth Care

H1B Sponsor Likely

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Responsibilities

Lead 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

Propose and lead data acquisition strategy, methodology, and approach for safety evaluations

Lead analysis of safety data and author safety assessment

Collaborate with PSLs, Safety 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

Prepare and support the 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

Lead 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

Lead the review of safety data and monitor the safety of patients on allocated clinical trials

Lead 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

Lead 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

Lead Safety Science specific investigator training

Lead the 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 and fulfill additional evaluation requests from health authorities (e.g., PRAC PSUSA) for assigned compounds

Identify safety related questions from the review of inquiries and assess the impact to applicable safety documents or safety section of clinical or regulatory documents.

Support strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs

Author Health Hazard Evaluations

Contribute to integrated Benefit/Risk assessments

Contribute to effective execution, communication and influence with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies)

Contribute to continuous employee development programs, such as mentoring, coaching, and peer-to-peer learning

Contribute to and provide Safety Science training to support team development

Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are medium in complexity

Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with internal processes, local laws and regulations

Execute any other tasks assigned by manager to assist in departmental activities

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Signal DetectionSafety Data EvaluationPharmacovigilanceRegulatory SubmissionsAdvanced ExcelAdvanced PowerPointAdvanced WordArgus DatabaseMedDRAData Mining ToolsClinical Trial SupportPharmaceutical DevelopmentGlobal Regulatory RequirementsSpotfirePowerBI

Required

Support assigned compounds in conjunction with Product Safety Leads (PSLs)

Leverage clinical and scientific expertise to perform signal detection, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting

Provide medical safety assessment

Apply effective prioritization, critical thinking, and judgment-based decision making to execute key deliverables in compliance with global regulations and internal processes

Effective communication and influence with internal and external stakeholders

Lead 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

Propose and lead data acquisition strategy, methodology, and approach for safety evaluations

Lead analysis of safety data and author safety assessment

Collaborate with PSLs, Safety Scientists, Pharmacoepidemiologists, and other cross-functional personnel as appropriate

Execute signal assessment analysis per strategy and assist with the preparation of presentations for Safety Management Team and Company Safety Committee

Prepare and support the presentation of safety data at safety governance meetings

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

Lead the development, update, and review of safety communication documents

Lead the review of safety data and monitor the safety of patients on allocated clinical trials

Lead the authoring and review of safety sections of regulatory submissions

Support the authoring of Storyboards and Briefing Books for HA interactions

Support ad-hoc review of the Safety Management Plans

Lead Safety Science specific investigator training

Lead the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports

Provide high quality support and fulfill additional evaluation requests from health authorities

Identify safety related questions from the review of inquiries and assess the impact to applicable safety documents

Support strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs

Author Health Hazard Evaluations

Contribute to integrated Benefit/Risk assessments

Contribute to effective execution, communication and influence with internal and external stakeholders

Contribute to continuous employee development programs

Demonstrate knowledge and application of pharmacovigilance principles

Adhere to requirements in quality system document and process improvement initiatives

Execute any other tasks assigned by manager to assist in departmental activities

Time Management and Prioritization

Demonstrate Initiative

Analytical Thinking/Data Analysis

Results-Oriented

Communicates with Clarity

Actionable Feedback

Fosters Teamwork

Advanced knowledge working with a safety database (i.e., Argus)

Advanced knowledge of MedDRA and signal management system

Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva)

Advanced knowledge of data mining tools and analyses tools such as Spotfire and PowerBI

Pharmaceutical product development experience

Experienced in global regulatory requirements for pharmacovigilance

Benefits

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Company

BeiGene

Glassdoor

3.1

BeiGene is a global oncology company.

Founded in 2010

Cambridge, Massachusetts, USA

10001+ employees

https://www.beigene.com

H1B Sponsorship

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Trends of Total Sponsorships

2023 (28)

2022 (36)

2021 (34)

2020 (22)