Leah Blough

About Leah Blough

HIghly experienced Clinical Safety Analyst/Safety Review Specialist with 20+ years of direct patient care as a registered nurse and 17 years of Pharmaceutical Industry experience. I am part of a network of clinical professionals who evaluate clinical safety data and communicate critical findings while providing comprehensive oversight of a product throughout its life cycle, with a focus on patient safety and data integrity.

Experience

1. Senior Clinical Safety Analyst

   AbbVie

   Aug 2016 — Present · Abbott Park, IL, US

   Responsible for compliance with applicable Corporate and Divisional Policies and procedures.• Collecting, analyzing, and triaging Adverse Events including reporting Serious Adverse Events to Investigational New Drug (IND) safety including follow-up.• Timely assessment of adverse event coding for consistency and accuracy of coding.• Timely, accurate and effective medical review of safety-related Clinical Review Forms (CRFs) and labs, including communication with Study Designated Physicians.• Interface with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, Pharmacovigilance and others to assure query resolution.• Supervises tracking of safety -related queries to Investigators.• Assist in handling safety questions from Institutional Review Board/International Electrotechnical Commission (IRB/IEC).• Effective communication of study-related information to Clinical Team members.• Assists with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians.• Provide Safety training/overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed.• Coaching and mentoring of designated Safety staff on safety activities.• Safety review of study protocols, IND reports, annual reports, Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, and other ad hoc reports which include safety data.• Database reconciliation utilizing accepted standardized processes.• Participation with planning and completion of Ad-Hoc Safety Reports.• Creation of narratives of serious adverse events and other identified adverse events of interest in accordance with accepted standards.• Application of knowledge of International Committee on Harmonization (ICH)/FDA regulations and guidelines affecting drug safety issues to assigned responsibilities. In depth understanding of product labeling/literature, and safety profile.

Education

• University of Wisconsin-Milwaukee

  Bachelor of Science, Nursing

  1985 — 1989

• Carthage College

  Paralegal studies

Skills

• Drug Safety
• Pharmacovigilance
• Therapeutic Areas
• Ctms
• Critical Care
• Ich-Gcp
• Meddra
• Oncology
• Hospitals
• Clinical Trials
• Gcp
• Training
• Nursing
• Clinical Research
• Pediatrics
• Public Speaking
• Infectious Diseases
• Research
• Healthcare
• Neurology
• Process Improvement
• Strategic Planning