Senior Drug Safety Specialist
On-siteSão Paulo, São Paulo, Brazil
Job Summary
Process Individual Case Safety Reports by validating cases, determining day-zero, reviewing source documents, and escalating special safety situations. Perform medical coding, narrative writing, listedness assessments, follow-up determination, and Analysis of Similar Events. Ensure workflow compliance through database timeline reviews and reconciliation between clinical trial and safety systems. Execute due diligence activities including query distribution and external reporter follow-ups while contributing to compliance, productivity, and quality metrics. Support continuous improvement initiatives and inspection readiness by making operational decisions aligned with SOPs and regulatory standards. Collaborate with Safety Operations, Medical Review, and Clinical Operations stakeholders.
Required Qualifications
- Understanding of global pharmacovigilance regulations (ICH, GVP, FDA, EMA, MHRA, NMPA, etc.)
- Experience with safety databases and case processing (intake, triage, coding, narratives, due diligence)
- Bachelor's degree in Life Sciences, Nursing, Pharmacy/PharmD, or other healthcare-related field
- Advanced English
- Minimum 1 year of experience in drug safety/pharmacovigilance or relevant clinical experience
- Previous experience in the pharmaceutical industry
Desired Qualifications
- Clinical knowledge of therapeutic areas and drug classes
- Advanced Spanish
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.