Patient Safety Specialist – Manila

About the role

The Patient Safety Specialist supports global pharmacovigilance activities across clinical trials and post‑marketing projects. Working from Manila, you will contribute to safety processes, ensure regulatory compliance, and collaborate with cross‑functional teams to deliver high‑quality safety deliverables.

Key responsibilities

• Maintain up‑to‑date knowledge of safety profiles, labeling, and international/local regulations.
• Implement project‑specific procedures, workflows and support compliance with reporting timelines.
• Assist in audit and inspection preparation, review metrics and participate in continuous‑improvement initiatives.
• Process Individual Case Safety Reports (ICSRs), prepare case documentation, generate routine safety reports and listings.
• Support safety submissions to authorities, portal/gateway setup and product registration processes.
• Conduct literature searches, screen publications for adverse drug reactions and report findings.
• Collaborate with clients, medical directors and cross‑functional teams; mentor new team members as needed.

Required profile

• Experience in pharmacovigilance, safety reporting and ICSR processing.
• Familiarity with regulatory reporting requirements and audit preparation.
• Ability to work independently, manage multiple tasks and communicate effectively with internal and external stakeholders.

Required skills