Extract, aggregate and summarize adverse event data for trending purposes and for use in safety, label, and product improvement initiatives
Perform preliminary review and analysis of select product adverse events, technical data and available scientific literature to support potential hypotheses generation
Conduct hypothesis generation of adverse events for QA investigation GMP compliance
Initiate further product review based on hypothesis or particular event of interest or concern and appropriately escalate findings to Manager
Responsible for all AE data extraction projects and requests from other departments including Regulatory, Medica Affairs, Brand, International Registration, Media, Legal and Quality Assurance
Assist Pharmacovigilance Sr Specialists in follow up tasks required for timely review, documentation and assessment of adverse event regulatory reporting and any 3rd party PV vendor submissions
Advise and support other associates with maintaining case intake compliance with DSHEA and MoCRA
Maintain working knowledge of nutrients/ingredients and structure function claims
Command of internal procedures and systems used
Consumer Affairs Representative
The Nature's Bounty Co.
10.2011 - 12.2012
Received, processed, monitored and reported complaints involving Quality issues and Adverse events
Worked closely with PV team and verified accurate capture and timely and valid documentation of customer events.
Trained new Employees on Systems and Complaint Handling Procedures
Maintained a high volume of workload taking on average 50-70 consumer contacts per day
Clinical Dietetic Technician
Alice Hyde Medical Center
08.2010 - 08.2011
Worked with staff dieticians during menu development, ensuring optimal Macro and Micro nutrient content for diverse patient populations including special diets, diabetic, renal cardiac ect.
Completed in-patient dietary assessments and reassessments including sitting for patient discharge meetings
Ordered medical nutrition supplements for patients including Boost products
Calculated Enteral and Parenteral nutation needs for tube feed orders for high risk patients
Education
Associate of Science - Exercise Physiology
Suffolk County Community College
Selden, NY
Bachelor of Science - Human Nutrition And Dietetics
State University of Plattsburgh New York
Plattsburgh, NY
05-2010
Timeline
Pharmacovigilance Specialist
Nestle Health Science
01.2023 - 05.2025
Consumer Affairs Representative
The Nature's Bounty Co.
10.2011 - 12.2012
Clinical Dietetic Technician
Alice Hyde Medical Center
08.2010 - 08.2011
Associate of Science - Exercise Physiology
Suffolk County Community College
Bachelor of Science - Human Nutrition And Dietetics