Manager, Global ICSR Management
New
J
JobgetherPharmaceuticals, Biotechnology
This is a remote role in BrazilFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 5 years of experience in drug safety, pharmacovigilance, or relevant clinical operations
- Required Skills
- GCPMicrosoft Office
Requirements
- Bachelor’s degree in life sciences, clinical medicine, nursing, pharmacy, or equivalent; advanced degree preferred.
- At least 5 years of experience in drug safety, pharmacovigilance, or relevant clinical operations.
- Strong knowledge of global pharmacovigilance and regulatory requirements (ICH, GVP, FDA, GCP, NMPA/CDE).
- Experience with regulatory reporting requirements involving FDA, EMA, MHRA, and other competent authorities.
- Hands-on understanding of ICSR case processing (intake, triage, coding, narrative development, database management).
- Proficiency with Argus Safety or comparable safety databases.
- Strong proficiency in Microsoft Office tools (Excel, PowerPoint).
- Excellent written and verbal English communication skills; fluent English is required.
- Demonstrated ability to manage projects and deliver high-quality work within strict timelines.
- Experience overseeing team deliverables and representing functions during audits and inspections.
- Willingness to travel approximately 5% of the time.
Responsibilities
- Oversee ICSR triage, case processing, in-line quality control, workflow management, and timely completion of safety activities.
- Lead and monitor SAE reconciliation between safety and clinical databases, ensuring completion and resolving discrepancies.
- Establish, monitor, and analyze quality, compliance, productivity, and volume KPIs to implement corrective actions.
- Drive continuous improvement initiatives including process optimization, automation, and technology efficiency.
- Review workflow and case prioritization to ensure operational targets and regulatory timelines are achieved.
- Support audit and inspection readiness and serve as a subject matter expert during regulatory inspections.
- Deliver training and onboarding support for new team members and provide mentorship.
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