Associate, Post Market Safety

About You:

As a Safety Associate, Post Market Safety, you will be responsible for supporting the Post Market Consumer Complaint, Adverse Event Management Program to ensure dietary supplement and cosmetic regulatory compliance in an exciting, growing company. You will bring your experience in the dietary supplement and cosmetic categories and have experience in ensuring adverse event compliance in adherence to FDA guidelines and regulations. This expertise will enable Nutrafol to continue to grow as a competitive and agile business in the categories that we operates within. In this role, you will report to the QA Manager, Post Market Safety.

Responsibilities:

• Execute the day-to-day functions of the Post Market Consumer Complaint and Adverse Event Program:
• Ensure consumer contact follow-ups are conducted using appropriate questions as required
• Review adverse events to determine if they are potentially serious and escalate accordingly
• File serious adverse event reports with FDA as required for dietary supplements and cosmetic products
• Complete adverse event assessments and investigations
• Track and trend adverse events on a monthly and quarterly basis
• Monitor metrics and KPIs (key performance indicators)
• Work closely with 3rd party medical advisor/PV vendor as required
• Support the implementation of a consumer complaint, adverse event management database.
• Gather in-depth adverse event information to address specific inquiries from colleagues and collaborators.
• Ensure the program is prepared for internal/3rd party audits as well as regulatory inspections.
• Participate as an effective member of cross-functional teams.
• Demonstrate ability to work in a collaborative environment that emphasizes teamwork, collaboration, motivation, consensus, and team building.
• Support with additional projects as needed.

Requirements:

• Bachelor’s degree in quality assurance, regulatory, biology, chemistry, medical sciences, pharmacology, toxicology, etc.; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job
• 3+ years of direct US Dietary Supplement/Consumer Healthcare Quality experience
• 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
• Hands-on experience executing QA/regulatory compliance for a broad portfolio of dietary supplements or related products
• Effective prioritization skills and the ability to execute on multiple projects, collaboratively and independently, in an agile environment
• Proven ability to communicate and collaborate effectively with a variety of audiences, both internal and external
• Strong analytical, organization and critical thinking skills