Pharmacovigilance professional supporting clinical research and post-marketing safety operations for gene therapy products. Responsible for compliant processing, evaluation, and documentation of safety data in accordance with ICH-GCP, ICH E2 guidelines, FDA, EMA, and global pharmacovigilance regulations. Demonstrates competency in safety data integrity, regulatory reporting, inspection readiness, and cross-functional collaboration within clinical research environments.
Core Competencies:
Individual Case Safety Report (ICSR) lifecycle management
ICH E2A, E2B(R3), E2D compliance
FDA, EMA, and GVP regulatory requirements
Serious Adverse Event (SAE) processing
MedDRA coding and medical terminology
Regulatory reporting timelines (7/15-day reporting)
Quality control (QC) and data verification
Inspection and audit readiness
Data privacy compliance (GDPR, HIPAA)
Cross-functional collaboration in clinical research settings
Key Responsibilities
Perform end-to-end processing of ICSRs in Oracle Argus Safety in compliance with global regulatory requirements.
Review, assess, and document SAEs for accuracy, completeness, seriousness, expectedness, and causality.
Conduct MedDRA coding of adverse events, medical history, and concomitant medications.
Ensure adherence to regulatory reporting timelines for expedited and non-expedited submissions.
Execute quality control (QC) review to ensure data integrity and regulatory compliance.
Utilize Medidata PV systems to support pharmacovigilance activities within clinical development programs.
Work with Case Intake Automation systems to ensure accurate intake, triage, and workflow management of safety reports.
Support reconciliation activities between safety and clinical databases.
Prepare cases for regulatory submission in E2B format.
Contribute to audit and inspection readiness by maintaining accurate documentation and compliance with SOPs and Work Instructions.
Systems & Tools
Oracle Argus Safety
Medidata Pharmacovigilance (PV) platform
Case Intake Automation System
MedDRA Coding DictiMore...
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