Pharmacovigilance Specialist

Job Description

Monitoring of incoming reports from various sources including mailboxes, EudraVigilance, and literature search results.

• Downloading of L2A (Regulatory authority) and MLM cases from EV Web on regular basis by using client specific filters for triage process.
• Triage of incoming reports for complete Agreeness, duplicate check, legibility, and validity.
• Perform literature searches according to search strategy.
• Responsible for coding all medical history, events, drugs /procedures/indication and laboratory tests according to the appropriate dictionary such as MedDRA, Company Product Dictionary, WHO-DD
• Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
• Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs).
• Maintaining of respective trackers required for the process and client delivery.
• Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for adverse event reporting.
• Ensures that the expectedness, causality assessment as well as seriousness criteria are accurate for the events.
• Request follow-up and perform query management, as applicable.
• Attending internal, drug safety and project-specific training sessions.
• Performs training assigned on internal and client Learning Management System (LMS) as applicable within designated timelines.