Origin: a Latin derivative
meaning "Gift of the Earth."
At doTERRA we encourage all employees to seek out opportunities that will expand their skill set. We strive to help achieve personal career goals by providing opportunities of growth and movement throughout the company.
Job Description: The Product Safety Officer is responsible for the documentation and review of adverse reactions reported to doTERRA. He/she is on-call 24/7 or act as a back up to another Product Safety Officer to be available for Poison Control, Physicians or customers that might need specific information about doTERRA products in order to treat an adverse reaction. The Product Safety Officer is also responsible for follow-ups, investigations and trends tracking of reported adverse reactions.
- Review all reported Adverse Events and follow-up with customers per doTERRA standard operating procedures.
- Accurate and timely collection and documentation of relevant data on domestic and foreign adverse events.
- Perform appropriate and timely follow-up and internal reporting per department guidelines, including accurate and thorough communication and documentation within the case.
- Identify Adverse Events which meet the definition of Serious Adverse Events, draft Serious Adverse Event reports and ensure accurate and timely submissions of required reports to regulatory agencies, and to doTERRA management within company and regulatory timeframes.
- Maintain sufficient knowledge of all doTERRA products to ensure professional and knowledgeable discussions with consumers and healthcare providers and dissemination of accurate product information in response to queries.
- Provide high-level customer service to consumers, health care professionals and internal customers.
- The Product Safety Officer is on-call 24/7 to be available for customers with emergencies related to doTERRA products and especially Poison Controls and Physicians that might need specific information about doTERRA products in order to treat an adverse reaction.
- A key member of a number of cross-functional teams including Quality Control and Quality Assurance teams within the company.
- Key role in the adverse event report reviews and causality assessments, collecting the relevant information and making assessments.
- Review adverse event report trends and advise on product reviews.
- Participate in continuous improvement of standard operating procedures related to Product Safety.
- Assist in establishment of company safety policies and procedures for product safety to protect humans, animals and the environment
- Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental standard operating procedures.
- Other related duties as needed within the Product Safety Department
- Registered Nurse or equivalent medical background.
- At least 8 years work experience in a GMP-regulated environment such as dietary supplements or pharmaceuticals.
- In-depth understanding of all GMP-regulated quality unit responsibilities and AER management following the current federal regulation (CFR) guidelines.
- Experience with FDA’s Adverse Event Reporting System.
- Proficiency in Microsoft Word, Excel, SAP, Adobe Acrobat and other programs specific to AER management
- Professional with demonstrated ability to work independently
- Advanced communication skills, work well with multiple teams within the company, excellent people and phone skills
- Organize and prioritize tasks
- Recognize potential issues and work proactively to avoid future issues
We are currently accepting applications for this position.
|Function:||Quality Control - MFG|
doTERRA International, LLC. is committed to employing a diverse workforce. Qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, protected veteran status, or disability.