Safety Case Processing Specialist | PV Operations

About the role

As a Pharmacovigilance Case Processing Associate, you will be responsible for processing and managing Individual Case Safety Reports (ICSRs) and play a critical role in ensuring the accurate processing and reporting of safety cases that support global patient health.

Key responsibilities

• Processing and managing Individual Case Safety Reports (ICSRs)
• Performing accurate case intake, book-in, and data entry
• Writing and updating medical narratives
• Conducting medical coding and product coding activities
• Reviewing cases using quality control tools and self-check processes
• Managing case routing, workflow updates, and case closure activities
• Performing labeling activities, including USPI labeling where applicable
• Supporting case reconciliation and compliance with regulatory timelines
• Maintaining documentation quality and data accuracy within safety systems

About you

Educational Background

• Bachelor's Degree, Master's Degree, or Doctorate in: Pharmacy, Life Sciences, Medical Sciences, Nursing, Biology, Biotechnology, or Related Healthcare or Scientific disciplines
• Professional license is preferred but not required

Required Experience

• 1-2 years of Pharmacovigilance or Drug Safety experience
• Experience processing safety cases within: Argus Safety, Veeva Safety, or Other Pharmacovigilance Safety Databases
• Experience with: Medical coding, Case processing, Narrative writing, Quality review activities
• Strong English communication skills (written and verbal)

Preferred Qualifications

• ICSR processing
• MedDRA coding
• WHO Drug coding
• Global Pharmacovigilance operations
• Regulatory reporting requirements
• Clinical research or drug safety operations
• Life Sciences Shared Services or BPO environment