Explore my specialized services designed to ensure regulatory compliance and optimize your operations in local Pharmacovigilance or Pharmacovigilance auditing. Learn more about how I can support you as a trusted partner.
With 15 years of hands-on experience in pre- and post-marketing pharmacovigilance, I offer a proven track record as a reliable Local Contact Person for Pharmacovigilance in Belgium and Luxembourg. Having served as the contact point for Health Authorities on behalf of more than 25 Marketing Authorization Holders, I bring unparalleled expertise in ensuring seamless regulatory compliance for your business.
My services include weekly local literature screening, staying ahead with proactive regulatory intelligence, and acting as a trusted liaison with authorities to address all pharmacovigilance requirements and queries. I ensure timely submissions, clear communication, and the implementation of local regulations to safeguard your compliance.
Partner with me to benefit from tailored support that minimizes risks, optimizes your pharmacovigilance processes, and strengthens your compliance in the highly regulated Belgian and Luxembourgish markets. With a deep understanding of the local PV landscape, I am committed to delivering quality, reliability, and peace of mind for your operations.
As a PV lead auditor, I offer expert auditing services tailored to meet global and local regulatory standards. I specialize in post-marketing PV audits, offering you a comprehensive evaluation of your processes against local and international regulatory requirements.
My PV audit services include the preparation of a targeted agenda that aligns with the audit scope, leveraging the information shared during a kick-off call. A thorough review of pre-audit documentation enables meticulous preparation for conducting the interviews with the appropriate stakeholders on each topic. The audit report is drafted using either Colibir’s template or yours and includes detailed coverage of the topics assessed and any observations raised. Additionally, I offer a review and validation of the proposed CAPA plan upon request.
With a deep understanding of pharmacovigilance regulations and best practices, I help you maintain a robust PV system, safeguard patient safety, and build trust with stakeholders. Let’s work together to enhance the compliance and efficiency of your pharmacovigilance operations.
Navigating pharmacovigilance (PV) inspections can be complex and time-consuming, but with the right support, you can approach them with confidence. My PV inspection support service is designed to help you prepare thoroughly, ensuring compliance with regulatory requirements and demonstrating the robustness of your PV systems. From assisting with pre-inspection preparation activities to offering strategic guidance during and after the inspection, I provide tailored support that address your unique needs. With a deep understanding of global PV regulations as well as hands-on experience, I can help you showcase your compliance efforts effectively while mitigating risks.
My support goes beyond just preparation—I partner with you to ensure a seamless inspection experience. This includes conducting mock interviews and targeted interview coaching of interviewees, reviewing critical documentation to identify potential gaps and supporting you with building presentation decks as needed.
During the inspection, I can help with documentation review, back-room organisation, or scribing in the main inspection room. Post-inspection, I assist with the preparation and validation of CAPA plans to address findings and improve processes.
Whether you are about to market your first medicinal product in Europe and thus need to set-up a whole post-marketing PV system according to European GVP, or you have a PV Quality Management System (QMS) in place already but feel like it can be optimized, I can support your needs. With 15 years of hands-on PV experience as well as 6-year experience as a PV lead auditor, I provide PV QMS support services, tailored to your particular needs.
Let’s work together !