A Trusted Partner for Pharmacovigilance in the Philippines
Whether you're supporting a clinical trial or managing an approved product, PiVOT helps you navigate pharmacovigilance requirements in the Philippines with confidence.
Understanding the Role of Pharmacovigilance
Pharmacovigilance helps ensure medicines continue to be used safely throughout their lifecycle. It supports patient safety, strengthens benefit-risk assessment, and helps organizations meet their ongoing regulatory responsibilities.
Our pharmacovigilance services support Marketing Authorization Holders (MAHs), pharmaceutical companies, sponsors, CROs, and regional affiliates by providing the expertise needed to manage safety activities throughout the product lifecycle.
Practical Support Across the Product Life Cycle
PiVOT’s services are designed to support both project-based clinical trials and recurring long-term safety programs.
We work as an extension of your team, providing responsive and reliable support.
We work as an extension of your team, providing responsive and reliable support.
Why PiVOT is the Local Partner You Can Rely On
PiVOT combines Philippine expertise with globally aligned processes to help organizations manage safety activities with clarity and confidence.
Philippine Regulatory Expertise
We understand the local landscape and help you navigate requirements efficiently.
Audit-Ready Processes
We follow SOP-driven processes designed to support quality and inspection readiness.
Integrated Clinical Research Experience
Our experience across clinical and post-marketing programs allows us to provide practical support grounded in real-world operations.
Responsive Local Partnership
You'll work with a dedicated team that values clear communication, accountability, and collaboration.
Frequently Asked Questions
What pharmacovigilance (PV) services does PiVOT provide?
PiVOT provides end-to-end PV support— from case intake and triage to case processing, quality review, medical review, and regulatory submission package preparation (including cover letters).
Do you support both clinical trial PV and post-marketing PV?
Yes. PiVOT supports clinical trial PV reporting and post-marketing PV reporting with workflows tailored to each reporting context.
How can we report an adverse event (AE) to PiVOT?
Reports can be submitted through PiVOT’s active channels: PV hotline (during business days/hours), web form and email.
What happens after PiVOT receives a report?
PiVOT conducts receipt tracking, case validity checks, follow-up for additional medical information when needed, translation (when applicable), and triage/prioritization per regulatory expectations.
What does “case processing” include?
Case processing includes duplicate checks, case creation, data entry into the safety database, product/event coding, seriousness/labeling/causality assessment, and narrative writing focused on clarity and medical accuracy.
Which coding dictionaries do you use?
PiVOT supports WHO Drug Dictionary for product coding and MedDRA for event coding.
Is there quality and medical review before regulatory submission?
Yes. PiVOT performs quality review for accuracy and consistency, and a medical review to confirm coding, seriousness, labeling, and causality from a medical perspective.
Do you submit safety reports to the Philippine FDA?
PiVOT supports regulatory submissions to the Philippine FDA, including submission package and cover letter preparation, as well as logging the Philippine FDA acknowledgement when received.
Do you handle product complaints and PV training?
PiVOT can include product complaint capture in the e-reporting form when requested, and provides PV/drug safety training and refreshers for client teams as agreed.