Regulatory Affairs Officer and Pharmacovigilance Auditor

About the role

This position is integral to our mission of delivering safe, effective, and compliant pharmaceutical and medical device solutions to the healthcare market. You will serve as a key bridge between our business operations, regulatory bodies, and quality assurance teams, directly contributing to patient safety and organizational integrity.

1. Develop, implement, and maintain pharmacovigilance systems and procedures to monitor the safety of pharmaceutical products and medical devices
2. Conduct regular audits of pharmacovigilance operations to ensure compliance with regulatory guidelines and company policies
3. Prepare and submit regulatory submissions including safety reports, adverse event reports, and other required documentation to regulatory authorities
4. Liaise with regulatory agencies such as the Philippine Food and Drug Administration (FDA) and other international regulatory bodies
5. Monitor changes in regulatory requirements and advise relevant departments on necessary adjustments to maintain compliance
6. Evaluate and assess adverse events reported by healthcare professionals, patients, and other stakeholders
7. Maintain comprehensive documentation of all regulatory and pharmacovigilance activities, ensuring accurate and traceable records
8. Provide training and guidance to staff on pharmacovigilance practices and regulatory compliance requirements
9. Support product registration processes and coordinate with cross-functional teams during product launches and post-market surveillance
10. Identify trends and emerging safety signals from adverse event data and recommend preventative or corrective actions

1. Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field
2. Must be a licensed Pharmacist (PRC License holder)
3. At least 3–5 years of experience in Regulatory Affairs, Pharmacovigilance, Quality Assurance, or a related pharmaceutical function
4. Knowledge of pharmacovigilance, post-market surveillance, risk management, and regulatory compliance requirements
5. Familiarity with Philippine FDA regulations and regulatory submissions is an advantage
6. Strong analytical, documentation, communication, and interpersonal skills
7. Proficient in regulatory systems and databases
8. Ability to work effectively with cross-functional teams
9. Relevant certifications in Pharmacovigilance or Regulatory Affairs are an advantage

About us

PHILUSA Corporation is a proudly Filipino-owned company engaged in the marketing and distribution of quality healthcare, personal care, baby care, and household products. Established in 1957, PHILUSA has been serving families for more than six decades through trusted brands that promote health, wellness, and everyday living.

PHILUSA is committed to delivering world-class products that are affordable, accessible, and responsive to the needs of consumers. Our portfolio includes well-loved brands such as Babyflo, Cleene, Apollo, Albatross, Mediplast, RHEA Generics, and many others that have become household names across the Philippines.

Guided by our core values of Customer First, Passion for Excellence, Sense of Urgency, Integrity, and Malasakit, we continuously strive to create meaningful impact by touching the lives of Filipino families and contributing to the growth and well-being of our communities.

What We Offer

As part of our team, you will have the opportunity to contribute to trusted brands that touch the lives of families anywhere in the world.