Associate, Post Market Safety

Keep Growing with Nutrafol

We’re a growing company. Everything we do, we do to help people grow into the best version of themselves. As the pioneers of hair wellness, we create clinically tested products for hair growth and provide support for people at every step of their hair journey.

Our multi-factorial approach targets key root causes of hair thinning using a patented blend of standardized vitamins, minerals and natural ingredients -- and is recommended by over 7,500 physicians and hair professionals for trusted, reliable results. We never settle, and are continuously challenging existing treatments and methodologies to advance the frontier of hair science. As we help our customers grow, we grow too -- by embracing individuality and differences, leading by example, and empowering ourselves and others with our passion for wellness and innovation.

Keep growing. It’s our mantra. Our commitment to helping anybody and everybody committed to realizing their own potential to grow.

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

Perks & Benefits

• 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

 

California residents may review our CCPA notice here.