Senior Specialist, Global ICSR Management
New
J
JobgetherPharmacovigilance
BrazilFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 2 years of experience in drug safety, pharmacovigilance, or relevant clinical environments
Requirements
- Bachelor’s degree in life sciences, clinical medicine, nursing, pharmacy, or equivalent.
- Advanced education or specialized training in global patient safety or pharmacovigilance is preferred.
- At least 2 years of experience in drug safety, pharmacovigilance, or relevant clinical environments.
- Strong understanding of global pharmacovigilance and regulatory requirements including ICH, GVP, FDA, EMA, MHRA, and NMPA/CDE.
- Practical knowledge of ICSR case management including triage, medical coding, narrative development, and quality control.
- Experience with Argus Safety or comparable safety databases.
- Proficiency with Microsoft Office (Excel, PowerPoint); Visio knowledge is a plus.
- Fluent English with excellent written and verbal communication skills.
- Strong analytical, problem-solving, and time management abilities.
- Previous experience in the pharmaceutical or biotechnology industry is preferred.
Responsibilities
- Independently perform ICSR triage, case processing, and quality control across clinical trial, post-market, spontaneous, solicited, and literature sources.
- Ensure individual case safety reports meet accuracy, quality, compliance, and submission requirements for regulatory authorities.
- Conduct SAE reconciliation between safety and clinical databases while tracking completion against timelines.
- Identify, investigate, resolve, and escalate discrepancies found during case management or reconciliation.
- Apply operational policies and SOPs to make sound process-related decisions.
- Contribute to continuous improvement initiatives and problem-solving within ICSR management.
- Execute activities in accordance with pharmacovigilance agreements when collaborating with vendors or CROs.
- Support onboarding by training new team members and maintaining training materials.
- Collaborate with internal stakeholders and external partners to maintain compliant safety operations.
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