job title: Executive - Pharmacovigilance (Jubilant biosys)

Roles and Responsibilities

Accountabilities Scope of work

• Principle Accountabilities

• Case processing / data entry and related activities in the Argus safety database as per DE conventions within specified timelines.

• Participate in downloading, triaging, uploading and book-in of regulatory and EMA MLM ICSR reports.

• Participate in triaging and book-in of literature reports.

• Triage, Case book-in, data entry & archiving.

• Ensure use of PV-MedDRA for coding adverse reactions

• Documentation

• Ensure that pharmacovigilance SOPs, procedures, processes, and guidelines are adhered to communicate with external and internal customers in a timely manner, as per the requirement.

• Statutory Compliances

• Maintain an awareness of current legislation associated with the Worldwide Regulatory Pharmacovigilance requirements.

• Ensures regulatory compliance by providing timely, quality information for aggregate reports and signal review following SOPs and regulations.