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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Pharmacovigilance and safety data management, with a strong focus on signal detection, benefit-risk evaluations, and regulatory compliance. Proven ability to collaborate across cross-functional teams and mentor junior professionals in the field.
Highest-signal resume keywords
Pharmacovigilance ExperienceSignal DetectionRegulatory Decision-MakingSafety Data AnalysisICH GCP Understanding
ATS Keywords
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Hard Skills
Safety MonitoringQuantitative AnalysisQualitative AnalysisCase AdjudicationClinical Document ReviewAggregate Safety ReportsPharmacovigilance ExpertiseBenefit-Risk EvaluationData InterpretationSOP Updates
Soft Skills
Excellent Communication SkillsSelf-MotivatedTeam PlayerProblem-SolvingPrioritization
Tools & Technologies
Microsoft ExcelDatabase EntryGraphics Presentations
Industry Keywords
Pharmaceutical IndustryClinical SafetyGlobal Clinical Safety MethodologySafety Management TeamsPost-Marketing Safety Data
About the role
Key responsibilities & impact- Monitor, evaluate, and manage the safety profile of CSL products across their entire lifecycle
- Support ongoing assessment of clinical and post-marketing safety data
- Provide scientific expertise for benefit-risk evaluations and regulatory decision-making
- Collaborate with Global Safety Leads and stakeholders across Development, Medical Affairs, Regulatory Affairs, and Clinical teams
- Lead safety review and evaluation of safety data using quantitative and qualitative approaches
- Perform end-to-end signal detection and analysis across safety data sources
- Present meaningful summaries of safety data
- Review scientific and medical literature for important safety information
- Contribute strategic input to aggregate safety reports, including PSURs, DSURs, PADERs, and Risk Management Plans
- Organize and provide insights to internal cross-functional Safety Management Teams
- Support product development teams with pharmacovigilance expertise relating to clinical data
- Develop response strategies and perform analyses for safety-related internal or regulatory requests
- Mentor junior members of the Pharmacovigilance and Safety community
- Perform case adjudication, review clinical documents, support SOP updates, and provide subject matter expertise
- Report to the Vaccine Safety Science Lead
Requirements
What you’ll need- Bachelor’s or equivalent degree (depending on national educational system) required in the pharmaceutical, nursing or biological, or sciences
- 7+ years' Pharmacovigilance experience in multinational pharmaceutical industry
- At least 3 years’ experience as a Pharmacovigilance scientist or equivalent position in a closely related discipline
- Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines, and standards
- Ability to provide solutions for issues/challenges that may arise during the course of a project
- Knowledge and experience of safety monitoring and signal detection preferred
- Understanding of ICH GCP and drug development preferred
- Computer proficiency in basic database entry and graphics presentations (e.g., Microsoft Excel or equivalent)
- Excellent written and verbal communication skills in English, with the ability to evaluate, interpret and synthesize scientific data
- Self-motivated, able to prioritize and plan effectively
- Ability to work independently and as a team player, working in a cross functional environment
- Suitably qualified candidates in Melbourne, Zurich, Maidenhead UK, and King of Prussia are encouraged to apply
Benefits
Comp & perks- Equal Opportunity Employer
- Reasonable accommodation for any part of the application process
- Inclusion and Belonging culture
- CSL benefits information provided via the employer benefits page