Hybrid Patient Safety Lead: Pharmacovigilance & Compliance

Concrete Masters, Inc.; Manila; Híbrido; PHP 800.000 - 1.200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive base salary

Health and wellbeing programmes

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes

Learning and development opportunities

Descripción de la vacante

ICON is a global healthcare intelligence and clinical research organisation. The Patient Safety Senior Specialist will lead local pharmacovigilance activities and ensure compliance with local health authority regulations, GVP, and company policies.

You will oversee ICSRs, maintain the Pharmacovigilance System Master File, support RMPs, collaborate with Regulatory Affairs, Medical, and external vendors, and mentor the team while driving process improvements.

Formación

• Bachelor's degree in Pharmacy, Medicine, Life Sciences, or related field.
• Strong knowledge of pharmacovigilance principles, GVP, and local regulations.
• Experience in patient safety operations and regulatory safety reporting.
• Excellent analytical and communication skills.
• Ability to collaborate across cross-functional teams and with vendors.
• Willingness to report to client office 4x a week (BGC).

Responsabilidades

• Lead and oversee local PV and patient safety activities, ensuring regulatory compliance.
• Manage collection, processing, quality review, and timely submission of ICSRs and safety reports.
• Maintain local patient safety systems and the Pharmacovigilance System Master File.
• Support development and maintenance of local Risk Management Plans.
• Serve as primary local contact for health authority interactions, inspections, audits.
• Collaborate with Regulatory, Medical, Commercial, and external vendors.
• Oversee safety agreements and data integrity metrics.
• Deliver patient safety training and mentorship within the team.
• Support local and global projects and process improvements.

Conocimientos

Pharmacovigilance

GVP knowledge

Regulatory compliance

Attention to detail

Cross-functional collaboration

Educación

Bachelor's degree in Pharmacy, Medicine, Life Sciences

Descripción del empleo

ICON is a global healthcare intelligence and clinical research organisation. The Patient Safety Senior Specialist will lead local pharmacovigilance activities and ensure compliance with local health authority regulations, GVP, and company policies.

You will oversee ICSRs, maintain the Pharmacovigilance System Master File, support RMPs, collaborate with Regulatory Affairs, Medical, and external vendors, and mentor the team while driving process improvements.