Evaluate and process adverse event reports from clinical trials and post-marketed products, ensuring data accuracy and completeness.

Identify, analyze, and interpret safety signals to assess potential risks associated with drug products.

Prepare and submit safety reports, such as Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs), to regulatory authorities.

Collaborate with cross-functional teams, including medical affairs, clinical development, and regulatory affairs, to manage drug safety issues.

Maintain and update safety databases, ensuring compliance with global regulatory requirements and internal standard operating procedures (SOPs).

Conduct literature reviews to identify relevant safety information and update risk management plans.

Participate in safety meetings and contribute to the development of risk mitigation strategies.

Assist in the preparation of responses to regulatory inquiries regarding drug safety issues.

Support the development and implementation of pharmacovigilance training programs for internal staff.

Monitor safety data from various sources, including post-market surveillance and spontaneous reports.

Collect, document, and report adverse events from clinical trials and post-market surveillance, ensuring regulatory compliance.

Analyze safety data to identify potential drug-related risks and trends, contributing to risk management plans.

Proactively detect and evaluate safety signals from various data sources, including literature and spontaneous reports.

Prepare and submit safety reports to regulatory agencies like CDSCO, ensuring adherence to local guidelines.

Develop and implement risk management plans to minimize potential risks associated with pharmaceutical products.

Monitor safety aspects of clinical trials, ensuring patient safety and data integrity throughout the study.

Participate in pharmacovigilance audits to ensure compliance with internal procedures and regulatory requirements.

Conduct literature reviews to stay updated on safety information and emerging trends in drug safety.

Maintain and update safety databases with accurate and complete information on adverse events.

Evaluate individual case safety reports to determine causality and assess the severity of adverse events.

Communicate with healthcare professionals to gather additional information on adverse events and clarify safety concerns.