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
Nutrafol takes into consideration a wide range of factors in final compensation decisions, including but not limited to: skill sets, experience and training, licensure and certifications, qualifications and education, and other business and organizational needs. The listed range is applicable only to the annual base salary and does not include additional perks, benefits, or applicable bonus eligibility comprising the total compensation package.
Salary Range:
$70,000—$90,000 USD
About the job
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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
Nutrafol takes into consideration a wide range of factors in final compensation decisions, including but not limited to: skill sets, experience and training, licensure and certifications, qualifications and education, and other business and organizational needs. The listed range is applicable only to the annual base salary and does not include additional perks, benefits, or applicable bonus eligibility comprising the total compensation package.
Salary Range:
$70,000—$90,000 USD