Hua Carroll

About Hua Carroll

Product safety physician with experience in both pre- and post-marketing environments.* Expertise in signal detection, benefit/risk assessment, and risk mitigation strategies.* In depth knowledge of FDA, ICH and EMA regulations and guidances.* Eighteen years\' experience in managing the clinical safety and pharmacovigilance department and products.* Expertise in MedDRA and WHODDE.Specialties: Pharmacovigilance, Clinical Safety, Safety Aggregate Reporting, Signal Detection, REMS, Adverse Event Coding, Drug Coding

Experience

1. Senior Director, Head Icsr Medical Evaluation Global Safety Officer

   Biogen

   Jun 2020 — Present · Cambridge, MA, US

   Manages an internal team of medical reviewers and external vendors conducting medical review. Oversees and accountable for the medical evaluation and assessment of post-marketing and clinical trial adverse event reports. Establishes and strengthens processes that ensure the accuracy and timeliness of medical review of adverse event reports. Develops strategies related to medical review, oversight, medical evaluation collaboration. Serves as a medical and pharmacovigilance expert for internal departments and external vendors.As Global Safety Officer, manages safety surveillance for assigned compounds/products. Provides safety strategic leadership for clinical development programs. Integrates the safety scientific component to build a strategic framework for clinical development plans. Develops and maintains relationships with program counterparts.

Education

• Beijing Medical University

  Doctor of Medicine (M.D.)

  1987 — 1993

• The University of Louisiana at Monroe

  Master of Science (M.S.), Psychometrics

  1998 — 1999

Skills

• Rems
• Pader
• Clinical Trials
• Medical Affairs
• Clinical Data Management
• Pharmaceutical Industry
• Sop
• Fda
• Drug Safety
• Clinical Development
• Signal Detection
• Clinical Safety
• Ctms
• Data Mining
• Meddra
• Ind
• Gcp
• Clinical Monitoring
• Psur
• Pharmacovigilance