Manager, Global ICSR Management
New
J
JobgetherPharmacovigilance
Remote in BrazilFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 5 years of experience in pharmacovigilance, drug safety, or relevant clinical environments
- Required Skills
- Project ManagementData AnalysisGCPMicrosoft Excel
Requirements
- Bachelor's degree in life sciences, medicine, nursing, pharmacy, or equivalent.
- At least 5 years of experience in pharmacovigilance or drug safety, including operational oversight.
- Strong understanding of global regulatory requirements (ICH, GVP, GCP, FDA).
- Hands-on experience with ICSR case processing (triage, medical coding, narrative development, quality management).
- Proficiency with safety databases, ideally Argus Safety.
- Strong technical skills in Microsoft Office (Excel, PowerPoint, Visio).
- Proven ability to analyze operational metrics and translate data into actionable improvements.
- Experience supporting regulatory audits and inspections.
- Excellent written and verbal communication skills in English.
- Strong project management and organizational skills.
- Demonstrated ability to mentor or supervise team members.
- Willingness to travel approximately 5%.
Responsibilities
- Oversee ICSR triage, case processing, and in-line quality control activities to ensure accurate and timely completion.
- Monitor workflows, balance workloads, and resolve operational issues to achieve KPIs.
- Lead SAE reconciliation activities between safety and clinical databases.
- Define and analyze quality, compliance, and productivity metrics to drive process improvements.
- Represent the pharmacovigilance function as a subject matter expert in audits and inspections.
- Support vendor and CRO activities to ensure operational alignment.
- Lead or participate in cross-functional projects and technology efficiency initiatives.
- Deliver onboarding and training for team members while providing ongoing coaching and mentorship.
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