Pharmacovigilance Safety Specialist – Mexico (Portuguese)

Syneos Health, Inc.; México; Hybrid; MXN 420,000 - 620,000; Full time

Job summary

Syneos Health is seeking a Safety Specialist for Mexico to support regulatory safety activities, including ICSR processing, data coding, and timely reporting of adverse events.

The role requires a life science degree, experience with safety databases and MedDRA coding, and strong communication skills. You will work within cross-functional teams to ensure compliance with global pharmacovigilance regulations.

Qualifications

• Bachelor’s Degree in life science, nursing, or pharmacy.
• Safety database systems and medical terminology knowledge.
• Understanding of clinical trial processes and pharmacovigilance.
• Proficiency with Microsoft Office Suite and basic IT tools.
• Strong written and verbal communication skills.

Responsibilities

• Enter information into PVG quality tracking systems for ICSR receipt and tracking.
• Triages ICSRs and evaluates data for completeness and regulatory reporting.
• Enter data into safety databases and perform MedDRA coding when needed.
• Assist in reporting expedited safety information in compliance with regulations.
• Maintain safety tracking for assigned activities and support TMF submissions.
• Participate in audits and ensure SOP/ICH/GVP compliance.

Job description

Syneos Health is seeking a Safety Specialist for Mexico to support regulatory safety activities, including ICSR processing, data coding, and timely reporting of adverse events.

The role requires a life science degree, experience with safety databases and MedDRA coding, and strong communication skills. You will work within cross-functional teams to ensure compliance with global pharmacovigilance regulations.