Pharmacovigilance Manager
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I am passionate about patient safety and maintaining high regulatory standards in pharmacovigilance. With over 14 years of experience in global clinical safety, drug safety operations, and compliance, I have developed strong expertise in handling ICSR case management, aggregate reports, signal detection, and quality systems.
In my current role as Manager – Drug Safety & Pharmacovigilance at Synapmed Global, I lead teams that ensure end-to-end PV operations run smoothly and meet global regulatory requirements. I focus on improving processes, supporting audits and inspections, and helping teams work efficiently and accurately.
I enjoy using data and technology to make safety processes more efficient and to support smart, informed decision-making. I value teamwork, continuous improvement, and maintaining the highest standards of compliance and quality.
Throughout my career, I have developed a robust background in global clinical safety and post-marketing surveillance. My work has consistently centered on the meticulous preparation and submission of Individual Case Safety Reports (ICSRs) and aggregate safety reports, where I have effectively ensured alignment with regulatory standards.
Pharmaceuticals, I played a pivotal role in managing compliance with both local and global regulations, ensuring that timely and accurate reports were submitted to regulatory bodies while developing key performance indicators (KPIs) to track efficacy and operational improvements.
Moreover, my academic credentials, including an MSc in Clinical Research from Cranfield University, combined with certifications such as PMP® from the Project Management Institute and Lean Six Sigma Green Belt, further solidify my ability to deliver strategic improvements and data-driven solutions in fast-paced environments.