Adverse Event Reporting:
Receive, review, and document adverse drug reactions.
Ensure compliance with regulatory requirements for safety reporting.
Data Analysis & Case Assessment:
Analyze case reports for severity, causality, and outcome.
Ensure accurate and timely submission of safety data to regulatory authorities.
Regulatory Compliance:
Maintain knowledge of local and global pharmacovigilance regulations (e.g., FDA, EMA, CDSCO).
Ensure internal processes comply with ICH-GCP and SOPs.
Collaboration:
Work with clinical teams, regulatory affairs, and medical experts to ensure patient safety.
Provide guidance and training to other staff on drug safety procedures.
Documentation & Reporting:
Maintain accurate records of drug safety data.
Prepare safety reports, risk management plans, and periodic safety update reports (PSURs).
Health insurance for employees and dependents
Provident Fund (PF) and retirement benefits
Paid leave, holidays, and sick leave
Performance bonuses or incentives
Training and professional development in pharmacovigilance
Flexible working arrangements or hybrid options in some 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