Analyst - R&D-1

Overview

The Analyst in PV Case Processing manages adverse event reports, ensuring data accuracy, completeness, quality, and compliance with global pharmacovigilance regulations and timelines.

What you'll do

• Perform data entry, seriousness assessment, and causality assessment of adverse event reports in the PV database.
• Identify case-processing issues that may delay submission and escalate them to management as appropriate.
• Develop an understanding of pharmacovigilance regulations.
• Comply with internal and external timelines for managing adverse events and product complaint case processing and case submission processes as appropriate.
• Validate data entry against source documents and call notes as appropriate.
• Assess adverse event reports for seriousness, reportabilities, and causality, including the reason for assessment.
• Perform self-review of all data for completeness, correctness, and quality.
• Ensure cases are complete, accurate, and ready for submission to appropriate regulatory authorities.
• Determine what follow-up information is needed, if any.
• Meet expected productivity and quality standards.
• Participate actively in team meetings.
• Perform other duties as assigned.

What you'll need

• Basic knowledge of medical terminologies and ability to understand common medical terms relevant to pharmacovigilance and adverse event reporting.
• Effective verbal and written communication skills to liaise with internal and external stakeholders.
• Ability to work effectively on multiple products and manage priorities effectively.
• Ability to establish and maintain effective working relationships with coworkers, managers, and relevant stakeholders.
• Ability to adhere to applicable global and local regulatory requirements.
• Skill in using multiple databases.
• Ability to support during high volumes and flexibility to work extended hours when required.
• Self-motivated, flexible, and receptive to changes.

Details

• Location: Bangalore, India.