THE POSITION
The Patient Safety Manager is responsible for helping shape patient safety and pharmacovigilance strategy in the Philippines. In this role, you'll lead the local Patient Safety & Pharmacovigilance agenda, ensuring robust pharmacovigilance systems, regulatory compliance, and the continued safety of patients and clinical trial participants.
If you're passionate about patient safety, compliance excellence, and making a meaningful impact on public health, we'd love to hear from you.
Tasks & responsibilities:
· Lead and execute the Philippines Patient Safety & Pharmacovigilance (PSPV) strategy aligned with global standards.
· Serve as the Local QPPV and primary contact for health authorities, inspections, and PV-related matters.
· Ensure compliance with local pharmacovigilance regulations, company policies, and marketing authorization requirements.
· Establish and maintain an effective local PV system to safeguard patient and clinical trial participant safety.
· Drive patient safety awareness and PV culture across the organization through collaboration and engagement.
· Lead, coach, and develop the local PSPV team while ensuring business continuity and operational excellence.
· Oversee adverse event reporting, PV submissions, risk management activities, and regulatory compliance.
· Manage local PV agreements, training programs, audits, inspections, and business contingency planning.
· Partner with internal and external stakeholders to support innovation and advance pharmacovigilance practices.
· Manage the local PSPV budget and ensure efficient use of resources.
Requirements:
• Degree in Pharmacy, Medicine, Pharmacology, Medicinal Chemistry, Pharmaceutics, or a related Healthcare field.
• 3-5 years of Pharmacovigilance (PV) experience, including team leadership experience.
• Strong knowledge of global, regional, and local PV regulations, GxP requirements, and patient safety principles.
• Solid understanding of drug development processes, therapeutic areas, and pharmacovigilance systems/databases.
• Proven ability to lead, influence, and collaborate with cross-functional local and global stakeholders.
• Strong analytical, problem-solving, and risk-based decision-making skills.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to manage multiple priorities and organize PV activities effectively in a fast-paced environment.
• Strategic, patient-centric mindset with a focus on continuous improvement and process innovation.
• Experience engaging with health authorities, regulators, healthcare professionals, patients, and internal stakeholders.
• Comfortable working with PV systems, dashboards, and data-driven insights.
• High level of professionalism, accountability, and stakeholder management skills.