Shahinaz Badr is the Founder and Managing Director of Vigilance Gate FZ LLC, a specialized pharmacovigilance and regulatory compliance consultancy providing strategic and operational support to regional and international organizations.

With over 20 years of experience across Pharmacovigilance (PV), Regulatory Affairs (RA), and Quality Management Systems (QMS), Shahinaz brings extensive expertise spanning the EU, Middle East, Africa, and emerging markets. A pharmacist by background with clinical practice experience, Shahinaz applies a patient-centered perspective to compliance, system design, and regulatory oversight. This foundation is complemented by a Lean Six Sigma Green Belt and certification as an ISO-qualified Lead Pharmacovigilance Quality (PVQA) Auditor, as well as expertise in process risk management and integrated management system auditing (ISO 9001, 14001, and 45001) supporting the development of PV systems that are compliant, sustainable, and inspection-ready. Shahinaz has supported global Marketing Authorization Holders and local distributors in ICSR management, signal evaluation, regulatory submissions, and inspection readiness. A specialist in vendor and distributor oversight, conducted risk-based audits and due diligence across EMEA to proactively mitigate regulatory risk, applying GAMP 5 principles to Computerized Systems Validation (CSV), ensuring PV infrastructures maintain data integrity and regulatory control.

Beyond consultancy, Shahinaz is a prominent contributor to drug and patient safety, authored multiple abstracts published with Springer Nature and currently serve as Co-Chair of the ISoP AI Special Interest Group (SIG), as well as PV Operations Sub-group Lead within the Industry SIG. A frequent speaker at international and regional forums, serving as Program Committee for the DIA Global QPPV Forum, contributing to scientific content development, and mentoring the next generation of pharmacovigilance professionals to strengthen global safety governance.