Patient Safety Senior Specialist - Manila - Hybrid

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Patient Safety Senior Specialist contributes to the core components of the local pharmacovigilance system, by ensuring the company has in place an effective pharmacovigilance system that complies with the local PV requirements.

What You Will 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.

Your Profile

You will have a strong foundation in pharmacovigilance and drug safety, with the experience to work independently and guide others.

Required Qualifications And Experience

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)

What ICON Can Offer You

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee Please click here to apply

Patient Safety Senior Specialist (Local PV)