Director, Risk Evaluation and Mitigation Strategies - Amneal Pharmaceuticals
Kal Elhoregy is an accomplished healthcare industry executive with 23+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems and Pharmacovigilance Compliance for companies within the pharmaceutical industry. In his current role as a Director, Risk Evaluation and Mitigation Strategy (REMS), Regulatory Affairs Clinical at Amneal Pharmaceuticals, he manages all REMS activities for multiple programs including operations and development of new programs and ensures the entity’s full compliance with the regulatory requirement and risk management standards and guidelines. As a strategist and accessible leader with experience in Pharmacovigilance and Quality Risk Management within the pharmaceutical industry, Kal has developed the infrastructure for managing all REMS programs in collaboration with multiple disciplines. He is known for his strong project management strategic skills, increasing organizational capacity through streamlining complex processes, and helping multiple disciplines to effectively manage compliance risk in accordance with regulatory guidelines with the main goals of ensuring patient safety and regulatory compliance. He is a registered and licensed Pharmacist and holds a Bachelor of Science, Accounting from the Faculty of Commerce, Ain Shams University and Bachelor of Science of Pharmacy from Arnold & Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, NY. His experience within the Health Care settings including Pediatric Intensive Care Units and Critical Care Unit Pharmacies, with main responsibilities as a lead infusion Pharmacist. Also his experience within the Pharmaceutical industry includes a strong expertise and leadership in Pharmacovigilance Compliance, Quality Risk Management and Quality System of PV, REMS, Risk Management Plan (RMP), Project Management, GVP / CSV Risk Based Audit, Validation strategies in PV, Good Clinical Practice QA, Vendor Management and Inspection Readiness. Kal believes in leadership and teamwork and focuses on what is important to achieve successful results in ensuring patient safety and regulatory compliance.
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