New Associate, Post Market Safety

About You:

• Supporting Post Market Consumer Complaint
• Adverse Event Management Program to ensure dietary supplement and cosmetic regulatory compliance.
• Experience in ensuring adverse event compliance in adherence to FDA guidelines and regulations

Responsibilities:

• Ensure consumer contact follow-ups are conducted using appropriate questions as required
• File serious adverse event reports with FDA as required for dietary supplements and cosmetic products
• Track and trend adverse events on a monthly and quarterly basis

Requirements:

• Knowledge and preferably experience of complaints and adverse event handling
• Knowledge and experience on FDA and applicable laws and regulations, as well as of cGMP standards
• Strong analytical, organization and critical thinking skills