Safety & Pharmacovigilance Specialist II (Hybrid, Mexico)

About the role

Syneos Health is seeking a Safety & Pharmacovigilance (PV) Specialist II to join its Clinical Solutions team in Mexico on a hybrid basis. The role supports drug development by managing safety data, ensuring regulatory compliance, and contributing to project plans.

Key responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSR.
• Assist in preparing Safety Management Plans and other project documentation.
• Set up, deliver, and close out safety and pharmacovigilance projects.
• Process ICSR according to SOPs and project‑specific safety plans.
• Tri­age ICSR, evaluate completeness, accuracy, and regulatory reportability.
• Enter data, code events, medical history, concomitant medications, and tests in the safety database.
• Compile narrative summaries and manage queries until resolved.
• Generate timely, accurate expedited reports in line with regulatory requirements.
• Coordinate with data management staff to reconcile safety data between clinical and safety databases.

Required profile

• Experience in pharmacovigilance and safety data management.
• Familiarity with ICSR processing and regulatory reporting standards.
• Ability to work independently and collaborate with cross‑functional teams.

Required skills

• Pharmacovigilance (PV) systems
• Safety database entry and coding
• ICSR processing
• Regulatory reporting

What we offer

• Career development and progression within a global life‑sciences organization.
• Supportive line management and peer recognition programs.
• Inclusive culture that values authenticity.