Kal Elhoregy

An accomplished healthcare industry executivewith 25+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems and Pharmacovigilance Quality and Compliance for companies within the pharmaceutical industry.

In his current role as a Director, Risk Management and Pharmacovigilance Compliance - Global Patient Safety at Amneal Pharmaceuticals, he manages all Global Risk Management activities including Risk Evaluation and Mitigation Strategies (REMS), Risk Management Plans (RMP) and the Pharmacovigilance Compliance unit and ensures the entity’s full compliance with the regulatory requirements of Pharmacovigilance and Risk Management.

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 and RMPs 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, GoodClinical 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.

An accomplished healthcare industry executivewith 25+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems and Pharmacovigilance Quality and Compliance for companies within the pharmaceutical industry.

In his current role as a Director, Risk Management and Pharmacovigilance Compliance - Global Patient Safety at Amneal Pharmaceuticals, he manages all Global Risk Management activities including Risk Evaluation and Mitigation Strategies (REMS), Risk Management Plans (RMP) and the Pharmacovigilance Compliance unit and ensures the entity’s full compliance with the regulatory requirements of Pharmacovigilance and Risk Management.

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 and RMPs 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, GoodClinical 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.

EDUCATION & TRAINING: 

Bachelor of Science, Pharmacy, Arnold & Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, NY 1997

Bachelor of Science, Accounting, Faculty of Commerce, Ain Shams University, Cairo, Egypt 1989