Manage and process adverse event reports from clinical trials and post-marketed products, ensuring timely and accurate data entry into safety databases.

Conduct thorough safety reviews of individual case safety reports (ICSRs) to identify potential safety signals and trends.

Prepare and submit safety reports, such as Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs), to regulatory authorities like CDSCO.

Collaborate with medical affairs, clinical development, and regulatory teams to address safety-related queries and contribute to risk management plans.

Participate in signal detection activities, including literature reviews and data mining, to identify potential drug safety issues.

Maintain up-to-date knowledge of pharmacovigilance regulations and guidelines, including those specific to India (CDSCO) and global regions.

Assist in the development and maintenance of pharmacovigilance standard operating procedures (SOPs) and training materials.

Support audits and inspections by regulatory authorities, ensuring compliance with pharmacovigilance requirements.