Drug Safety Assistant

ProPharma Group; Hyderabad; Sur place; INR 300 000 - 500 000; Plein temps

Résumé du poste

ProPharma Group in Hyderabad, India seeks a Pharmacovigilance support specialist to assist in monitoring and reporting adverse drug reactions and safety concerns.

You will collect, review, and process safety reports from patients and healthcare professionals, enter data into PV databases, and help prepare ICSRs within deadlines.

The role requires meticulous record review and collaboration with teams to ensure data integrity and regulatory compliance.

Responsabilités

• Assist in monitoring and reporting adverse drug reactions and other drug safety concerns.
• Collect, review, and process safety reports from patients, healthcare professionals, and other sources.
• Enter and maintain accurate drug safety information in pharmacovigilance databases.
• Support the preparation and submission of Individual Case Safety Reports (ICSRs) within specified timelines.
• Review medical records and source documents for completeness and accuracy.

Connaissances

Pharmacovigilance

Adverse Drug Reaction reporting

ICSR submission

Data entry

Description du poste

• Assist in monitoring and reporting adverse drug reactions and other drug safety concerns.
• Collect, review, and process safety reports from patients, healthcare professionals, and other sources.
• Enter and maintain accurate drug safety information in pharmacovigilance databases.
• Support the preparation and submission of Individual Case Safety Reports (ICSRs) within specified timelines.
• Review medical records and source documents for completeness and accuracy.