Patient Safety Senior Specialist – Local Pharmacovigilance

About the role

ICON plc is seeking a Patient Safety Senior Specialist to lead local pharmacovigilance (PV) activities in Manila. This hybrid position ensures the company’s PV system meets local regulatory requirements while supporting global safety initiatives.

Key responsibilities

• Lead and oversee local PV and patient safety operations, ensuring compliance with health authority regulations, Good Pharmacovigilance Practice (GVP) and company policies.
• Manage collection, processing, quality review and timely submission of Individual Case Safety Reports (ICSRs) and other safety documentation.
• Maintain the local Pharmacovigilance System Master File (PSMF) and patient safety procedures to ensure regulatory readiness.
• Support development and maintenance of local Risk Management Plans (RMPs) and risk‑minimisation activities.
• Act as primary contact for health authority queries, inspections and audits, delivering prompt and effective responses.
• Collaborate with Regulatory Affairs, Medical Affairs, Commercial, Clinical Operations and external vendors to ensure compliance.
• Oversee vendor performance, safety agreements and compliance metrics.
• Provide patient safety training, mentorship and promote a strong compliance culture.

Required profile

• Bachelor’s degree in Pharmacy, Medicine, Life Sciences or related field.
• Strong knowledge of pharmacovigilance principles, GVP and local health authority regulations.
• Proven experience in patient safety operations and regulatory safety reporting.
• Excellent analytical, problem‑solving and decision‑making abilities with high attention to detail.
• Effective written and verbal communication skills for cross‑functional collaboration.
• Experience in vendor and project management, driving process improvements.

Required skills

• Pharmacovigilance
• Good Pharmacovigilance Practice (GVP)
• Regulatory safety reporting
• Risk Management Plans (RMP)
• Vendor management
• Project management