Associate, Post Market Safety

• 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
• 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

• Bachelor’s degree in quality assurance, regulatory, biology, chemistry, medical sciences, pharmacology, toxicology, etc.; or an equivalent combination of education and experience
• 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

Pay range: $70K - $90K

• Fully remote work experience
• Comprehensive medical, dental, and vision package, including FSA program
• 401K with employer match
• Quarterly Bonus Program
• Flexible PTO
• Two company-wide wellness breaks every day
• Free lunch on us every Tuesday and Thursday via Seamless/Grubhub
• Monthly wellness stipend
• Monthly internet stipend
• Monthly cell phone stipend
• Annual learning & development stipend
• Wellness Program, including virtual Wellness Sessions & No-Meeting Wednesdays
• Free meditation app membership (Headspace)
• Free Nutrafol subscription
• Pet insurance discounts and benefits