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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical drug safety and risk management, with a strong foundation in medical qualifications and experience in biopharmaceutical development. Proficient in data analysis, communication, and project management within a regulated clinical trial environment.
Highest-signal resume keywords
Clinical Drug Development ExperienceMedical Qualifications (MD; MB BS; MB ChB)Clinical Drug Safety ExpertiseGxP UnderstandingFluent in Mandarin and English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Signal DetectionICSR Medical ReviewDSUR/PBRER ReportingData AnalysisProject Management MethodologyRisk Management ActivitiesSafety Data ReviewScientific Publication ContributionClinical Medical ExpertiseSafety Strategy Development
Soft Skills
Excellent Written CommunicationExcellent Verbal CommunicationPresentation SkillsCross-Functional TeamworkMentoring and Training
Certifications & Qualifications
Board CertificationPost-Graduate Medical Qualifications
Industry Keywords
Biopharmaceutical IndustryClinical Trial LifecycleRegulated ProcessesSafety ScienceDrug Monitoring Committee
About the role
Key responsibilities & impact- Develop and maintain expert understanding of assigned products’ safety profiles and relevant strategic context
- Manage individual and aggregate case reporting, including ICSR medical review and DSUR/PBRER reporting
- Conduct signal detection and management, including STAR and ISMP maintenance
- Contribute to product safety strategy and Clinical Development strategy
- Contribute to risk management activities, including CCDS, IB labeling, risk communications, RMP, and REMS
- Provide safety input to study management, SMT/PET activities, and document review across the development continuum
- Review safety data and prepare relevant sections for IND, NDA, MAA, variation, and renewal submissions
- Prepare and maintain safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
- Participate in Drug Monitoring Committee and internal monitoring committee meetings
- Support presentation of safety issues to internal and external review and governance committees
- Author or contribute to scientific publications
- Independently manage safety responsibilities on study teams and safety science activities
- Provide clinical medical expertise and decision-making where required
- Coordinate with Safety Science vendors
- Train and mentor junior PCS scientists
- Lead medium- and high-priority projects and take on complex deliverables
- Potentially serve as Safety Strategy Lead for assigned molecules
Requirements
What you’ll need- Formal medical qualifications (e.g. MD; MB BS; MB ChB) and post-graduate experience in relevant clinical medical practice, or qualified healthcare professional or Life Sciences graduate
- Preferably relevant board certification(s), board eligibility, and/or other relevant post-graduate medical qualifications
- Typically 4 or more years of clinical drug development experience in the biopharmaceutical industry or related sector
- Preferably at least 2 years of experience in a clinical drug safety-related role
- Understanding of GxP and regulated processes and the end-to-end clinical trial lifecycle
- Strong orientation towards process improvement and cross-functional teamwork
- Ability to effectively work with remote partners on a global team
- Excellent written and verbal communication skills
- Ability to apply complex data analysis/statistical methods to evaluate, interpret, and present scientific data
- Strong presentation skills and ability to summarize and present key considerations and decision points
- Ability to train others on departmental practices and processes
- Application of project management methodology
- Fluent in Mandarin and English