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.

Analyze adverse event reports to identify potential safety signals and trends.

Evaluate individual case safety reports for completeness and accuracy.

Proactively identify and investigate potential drug safety issues.

Develop and implement risk mitigation strategies for pharmaceutical products.

Prepare and submit safety reports to regulatory authorities like CDSCO.

Conduct literature searches to stay updated on drug safety information.

Maintain and update pharmacovigilance databases with accurate data.

Ensure compliance with pharmacovigilance standard operating procedures (SOPs).

Participate in internal and external audits of pharmacovigilance systems.

Develop and deliver training programs on drug safety to healthcare professionals.

Work with cross-functional teams to address drug safety concerns.