FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance and medical evaluation, ensuring compliance with regulations and high-quality safety assessments. Capable of leading vendor oversight, training, and cross-functional collaboration to enhance safety processes and address complex medical issues.
Highest-signal resume keywords
Advanced Medical/Pharmacy DegreePharmaceutical/CRO Industry ExperiencePharmacovigilance KnowledgeMedical Assessment of Biologic ProductsRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical EvaluationCausality AssessmentICSR ManagementAdverse-Event GradingPharmacovigilance RegulationsSafety AssessmentProcess ImprovementRisk ManagementRegulatory ReportingComplex Medical Issue Management
Soft Skills
Clear CommunicationFeedback IncorporationLeadershipCollaborationTraining and Development
Industry Keywords
Pharmacovigilance SystemCIOMSBiologic ProductsVaccinesCombination ProductsHealth Authority QueriesVendor Performance MonitoringCross-Functional SolutionsSOP ComplianceSafety-Relevant Procedures
About the role
Key responsibilities & impact- Oversee vendor activities to ensure high-quality, timely medical evaluation and processing of individual case safety reports
- Apply medical and scientific judgment to assess safety information, including causality, expectedness, seriousness, and clinical relevance
- Ensure medical evaluation activities comply with pharmacovigilance regulations, company standards, and applicable SOPs
- Contribute to continuous process improvement, including review and enhancement of safety-relevant procedures
- Collaborate with internal GSPV functions, cross-functional stakeholders, and the vendor to ensure consistent, high-quality safety assessments
- Deliver onboarding training or knowledge-sharing activities to vendor Medical Evaluators
- Identify challenges, risks, and roadblocks associated with the global medical evaluation strategy and develop cross-functional solutions
- Support monitoring of vendor performance, training, workload, and issue resolution through governance and oversight
- Respond to health authority queries related to case medical evaluation
- Identify resources and tools needed to facilitate risks and implement risk-management initiatives
- Interface with high-level internal and external stakeholders
- Contribute to and approve regulatory reports, submissions, and responses to queries
Requirements
What you’ll need- Advanced Medical/Pharmacy Degree (e.g., MD or PharmD) or international equivalent
- Seven (7) years of pharmaceutical/CRO industry experience, a significant proportion of which should be in a medical evaluation role
- Broad overview of all aspects of a pharmacovigilance system and specific experience with regulatory requirements
- Experience in the medical assessment of complex biologic products, including vaccines and combination products, is desirable
- Deep knowledge of pharmacovigilance concepts, including CIOMS, listedness/expectedness, causality assessment, common adverse-event grading and coding conventions, and ICSR management
- Experience and success in addressing and managing complex medical issues in pre-approval and post-approval environments
- Ability to convey complex concepts through clear and concise messages
- Ability to demonstrate two-way communication by seeking and incorporating feedback
- Ability to provide appropriate direction, gain commitment, develop, and empower others
Benefits
Comp & perks- Employer-provided benefits; details available via “How CSL Supports Your Well-being | CSL”
- Inclusion and belonging initiatives
- Reasonable accommodation for applicants with disabilities