Analyst - PV Case Processing

Overview

The Analyst in PV Case Processing manages adverse event reports, ensuring data accuracy 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 issues in case processing that may delay submission and escalate them to management as appropriate.
• Develop an understanding of pharmacovigilance regulations.
• Comply with internal and external timelines for adverse event and product complaint case processing and case submission.
• Validate data entry against source document(s) and call notes as appropriate.
• Assess adverse event reports for seriousness, reportability and causality, including reason for assessment.
• Perform self-review of all data for completeness, correctness and quality, ensuring cases are ready for submission to regulatory authorities.
• Determine what, if any, follow-up information is needed.
• Meet expected productivity and quality standards.
• Actively participate in team meetings.
• Perform other duties as assigned.

What you'll need

• Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience, or M. Pharm with Pharmacovigilance Experience.
• Basic knowledge of medical terminologies and understanding of 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.
• Ability to establish and maintain effective working relationships with coworkers, managers and relevant stakeholders.
• Capable of adhering 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 change.

Nice to have

• 0-2 years of pharmacovigilance experience.

Details

• Location: India, Bangalore.
• Travel: 0%.