Safety Data Management:
Collect, review, and process adverse event (AE) and serious adverse event (SAE) reports.
Ensure all safety data is accurately entered into clinical databases.
Documentation & Reporting:
Maintain and update safety logs and case report forms (CRFs).
Support preparation of safety narratives and regulatory reports.
Regulatory Compliance:
Ensure safety reporting complies with ICH-GCP, FDA, EMA, and CDSCO guidelines.
Coordinate with clinical sites, investigators, and regulatory authorities.
Collaboration & Communication:
Work with clinical operations, data management, and medical writing teams.
Participate in safety meetings and audits to ensure compliance.
Health and life insurance coverage
Provident Fund (PF) and gratuity benefits
Paid time off and sick leave
Performance-based bonuses
Training in pharmacovigilance and regulatory systems
Hybrid / remote work options (in global organizations)
🔬 Services & Capabilities Medpace offers a full-service model encompassing all phases of clinical trials (Phase I-IV), providing services such as: Study Start-up and Clinical Trial Management Clinical Monitoring and Data Management... Read More