Patient Safety Senior Specialist - Manila - Hybrid

Job title: Patient Safety Senior Specialist - Manila - Hybrid

About the Role ICON is seeking a Patient Safety Senior Specialist to lead local pharmacovigilance activities in Manila, ensuring compliance with local PV requirements and GVP. This role focuses on building and maintaining an effective pharmacovigilance system and supporting safety initiatives.

What You'll Do

• Lead and oversee local pharmacovigilance (PV) and patient safety activities, ensuring compliance with local health authority regulations, Good Pharmacovigilance Practice (GVP), and company policies.
• Manage the collection, processing, quality review, and timely submission of Individual Case Safety Reports (ICSRs), safety reports, and other regulatory safety documentation.
• Maintain local patient safety systems, procedures, documentation, and the Pharmacovigilance System Master File (PSMF) to ensure ongoing regulatory readiness.
• Support the development, implementation, and maintenance of local Risk Management Plans (RMPs), risk minimization activities, and other product safety initiatives.
• Serve as the primary local contact for health authority interactions, patient safety queries, inspections, and audits, ensuring timely responses and effective corrective actions.
• Collaborate cross-functionally with Regulatory Affairs, Medical Affairs, Commercial, Clinical Operations, and external vendors to ensure compliance with pharmacovigilance requirements.
• Oversee local safety agreements, vendor performance, reconciliation activities, and patient safety compliance metrics to maintain data integrity and regulatory compliance.
• Deliver patient safety training, provide guidance and mentorship to team members, and promote a strong culture of pharmacovigilance compliance across the organization.
• Support local and global patient safety projects, business continuity planning, and continuous process improvement initiatives.

What We're Looking For

• Bachelor's degree in Pharmacy, Medicine, Life Sciences, or a related field.
• Strong knowledge of pharmacovigilance principles, Good Pharmacovigilance Practice (GVP), and local health authority regulations.
• Proven experience in patient safety operations, safety systems management, and regulatory safety reporting.
• Excellent analytical, problem-solving, and decision-making skills with strong attention to detail.
• Strong written and verbal communication skills, with the ability to collaborate effectively across cross-functional teams and external stakeholders.
• Experience in vendor management, project management, and driving process improvements.
• Ability to influence stakeholders, manage change, and resolve conflicts in a complex environment.
• Experience supporting audits and inspections and ensuring ongoing regulatory compliance.
• Leadership capabilities, including mentoring team members and acting as a role model within the patient safety function.
• Knowledge of relevant therapeutic areas and broader pharmaceutical business processes is an advantage.
• Willingness to report to client office 4x a week (BGC).

Nice to Have

• Knowledge of relevant therapeutic areas and broader pharmaceutical business processes is an advantage.

Compensation & Benefits

• Competitive salary and a range of benefits designed to support well-being and work-life balance.
• Various annual leave entitlements.
• Health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.