Evaluate and process Individual Case Safety Reports (ICSRs) from clinical trials and post-marketed products.

Conduct signal detection and management activities, including literature review and data mining.

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

Maintain and update the pharmacovigilance database with accurate and complete safety information.

Participate in risk management activities, including the development and implementation of Risk Management Plans (RMPs).

Collaborate with cross-functional teams, including medical affairs, clinical development, and regulatory affairs, to ensure patient safety.

Perform quality control checks on safety data and documentation to ensure compliance with regulatory requirements.

Monitor safety data from clinical trials and post-marketing surveillance to identify potential safety issues.

Assist in the development and maintenance of standard operating procedures (SOPs) related to pharmacovigilance activities.

Provide training and support to other team members on pharmacovigilance processes and regulations.

Stay updated with current pharmacovigilance regulations and guidelines from regulatory agencies like CDSCO and EMA.

Assist in the preparation for and conduct of regulatory inspections and audits.

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

Analyze safety data to identify potential safety signals and trends, contributing to risk management strategies.

Manage individual case safety reports (ICSRs), including data entry, assessment, and narrative writing.

Proactively detect and evaluate potential safety signals from various data sources, such as literature and databases.

Ensure compliance with global pharmacovigilance regulations and guidelines, including those from FDA, EMA, and CDSCO.

Develop and implement risk management plans (RMPs) to minimize risks associated with pharmaceutical products.

Maintain and update pharmacovigilance databases, ensuring data accuracy and integrity for safety reporting.

Conduct literature reviews to identify relevant safety information and update safety profiles of products.

Prepare for and participate in internal and external audits to ensure pharmacovigilance processes are compliant.

Develop and deliver training programs on pharmacovigilance to internal staff and external partners.

Collaborate with medical affairs, clinical development, and regulatory affairs teams on safety-related issues.