Joseph Lee, MD, MPH

Experience

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  Kaiser Permanente

  Jan 1996 - Jan 1999

  Staff Physician – Dept. of Internal Medicine

  - Clinical management of patients in outpatient and inpatient settings.- Conducted teaching and training of medical students and medical residents.

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  Hoechst

  Jan 1998 - Jan 2000

  Global Safety Officer Consultant –Dept. of Global Drug Safety and Surveillance

  - Involved in preparation and medical review of Periodic Safety Update Reports (PSUR’s).- Performed single case review of SAE reports.- Performed aggregate safety database review for safety signal detection.- Prepared responses to Regulatory queries from global regulatory authorities.- Therapeutic Areas: Anti-infectives

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  Sanofi-Aventis Pharmaceuticals

  Jan 2000 - Jan 2010

  Director, Medical Safety — Dept. of US Pharmacovigilance

  - Contributed to FDA and EMA approval for additional approved indication of acute myocardial infarction for the CV product, Enoxaparin (Lovenox).- Performed clinical and regulatory evaluation of SAE Adverse Event reports of post-marketed andinvestigational drugs for submission to FDA and global regulatory authorities.- Completed PSUR’s and US Periodic Safety Reports for assigned products for submission to FDA and other global regulatory authorities.- Participated in aggregate safety database review for safety signal detection.- Participated in close safety surveillance of top tier company products of Plavix and Allegra- Provided pharmacovigilance support to other departments, including Regulatory, Labeling, Medical Affairs,Marketing, Legal, Clinical Development and Medical Information.- Trained and mentored other safety physicians and staff within the pharmacovigilance department.- Therapeutic Areas: Cardiovascular/ Thrombosis (Plavix); Metabolism/ Diabetes (Lantus); Respiratory/Allergy, (Allegra); Neuroscience; Anti-infectives (Ketolide) Show less

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  Pfizer Pharmaceuticals

  Jan 2010 - May 2024

  Medical Director, Product Safety Surveillance & Reporting, Worldwide Safety

  - Collaborated with Clinical Development teams on Phase 3 study products for FDA NDA submission- Contributed to the FDA and EMA approval of the Rare Disease product, Tafamidis, for the approvedindications of amyloid cardiomyopathy and amyloid neuropathy.- Provided medical safety input to Clinical Development Teams, regarding potential safety signals and periodic safety aggregate review for Rare Disease study investigational compounds (Tafamidis) and immunology/rheumatology drugs (Enbrel).- Conducted medical safety assessment, including the determination of seriousness, expectedness, listedness, labeledness, and causality of adverse events in compliance with current ICH regulations.- Completed cases that meet SUSAR reporting criteria for submission to global regulatory authorities.- Identified and evaluated potential safety signals, based on individual cases and cumulative data assessment.- Collaborated with Risk Management Group in safety signal detection, labeling changes, and risk management activities.- Took responsibility for inspection readiness for medical assessment activities; supported regulatory authority inspections with FDA and EMA.- Mentored and trained Therapeutic Area safety colleagues to foster an environment of trust, understanding, learning, and development.- Therapeutic Areas: Neurosciences; Pain/ Inflammation/ Rheumatology/ Immunology; Cardiovascular/Metabolism; Respiratory: Vaccines/ID; Rare Diseases Show less

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  Jslmd Consulting LLC

  May 2024 - now

  Principal

  Medical Director (Consultant) at Boehringer Ingelheim, Ridgefield, CT- Conducted medical safety assessment, including the determination of seriousness, expectedness, listedness, labeledness, and causality of adverse events in compliance with current ICH regulations.- Completed clinical trial cases that meet SUSAR reporting criteria for submission to global regulatory authorities.- Identified and evaluated potential safety signals, based on individual cases and cumulative data assessment.- Therapeutic Areas: Oncology; Obesity; Inflammation/Immunology; Cardiovascular/Metabolism; Respiratory Show less