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Director – Safety Scientist
BeOne MedicinesDirector, Safety Scientist leading safety signal detection and risk assessment at BeOne. Collaborating on safety data evaluations and ensuring compliance with global regulations.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Safety Science and Pharmacovigilance, with a strong focus on safety data analysis, regulatory submissions, and effective communication of safety information. Proven ability to lead cross-functional collaborations and manage safety risks in clinical trials.
Highest-signal resume keywords
PharmacovigilanceSafety Data AnalysisRegulatory SubmissionsSafety Database ManagementClinical Experience
ATS Keywords
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Hard Skills
Safety Data EvaluationSignal DetectionSafety Risk AssessmentSafety Communication AuthoringRegulatory Inquiry AnalysisClinical Trial MonitoringSafety Management PlansMedDRA KnowledgeExcel ProficiencyPowerPoint Proficiency
Soft Skills
CollaborationCommunicationLeadershipOrganizational Effectiveness
Tools & Technologies
ArgusVeevaElectronic Document Management System
Certifications & Qualifications
PharmDNPRNPhD in Medical Field or Biological Science
Industry Keywords
Pharmaceutical IndustryBiotechnologyClinical DevelopmentClinical ResearchSafety Science
About the role
Key responsibilities & impact- Support assigned compounds in conjunction with Product Safety Leads (PSLs)
- Lead the detection of safety signals, evaluation of safety data, and assessment of safety risks
- Perform analysis of safety data and author safety assessments
- Drive collaboration with PSLs and cross-functional personnel for thorough evaluation of safety data
- Lead preparation and presentation of safety data at governance meetings
- Communicate relevant safety information timely to stakeholders
- Lead the authoring and reviewing of safety communication documents
- Support the review of safety data and monitor safety of patients on allocated clinical trials
- Author safety sections of regulatory submissions and manage Safety Management Plans
- Lead analysis of safety data for global regulatory inquiries and periodic reports
- Promote continuous improvement in organizational effectiveness and productivity
Requirements
What you’ll need- PharmD, NP, RN, or PhD in a medical field or biological science
- 8+ years of experience as a Safety (Pharmacovigilance) Scientist
- 4+ years of clinical experience with patients in a relevant therapeutic area specialty
- 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research
- 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)
- Prior matrix management team experience
- Prior experience with Regulatory Agency interactions
Benefits
Comp & perks- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness