Patient Safety Senior Specialist (Local PV)

Concrete Masters, Inc.; Manila; On-site; PHP 800,000 - 1,200,000; Full time

Benefits offered by this job

Competitive base salary

Health and wellbeing programmes

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes

Learning and development opportunities

Job summary

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.

Qualifications

• 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).

Responsibilities

• 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.

Skills

Pharmacovigilance

GVP knowledge

Regulatory compliance

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy, Medicine, Life Sciences

Job description

Patient Safety Senior Specialist - Manila - Hybrid

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a requesthere.