Specialist, Product Vigilance in Bohemia, NY at The Nature's Bounty Co.

Date Posted: 9/11/2018

Job Snapshot

Job Description


Company Description  

For more than 70 years, The Nature’s Bounty Co. has enriched the lives of consumers around the world and stood as the leader in health and wellness by introducing innovative products and solutions to the marketplace. Putting science and the highest quality standards at the heart of our business, the brands of The Nature’s Bounty Co. are some of the most trusted in the world. Always motivated by nature’s bountiful effects on people’s health, our vision for health and wellness has inspired leading brands such as Nature’s Bounty®, Sundown Naturals®, Solgar®, Osteo Bi-Flex®, Ester-C®, MET-Rx®, Pure Protein®, Balance®, Body Fortress®, Puritan’s Pride® and Organic Dr.®, among others. As a leading global manufacturer, marketer, distributor and retailer of vitamins, nutritional supplements, sports & active nutrition and ethical beauty products, The Nature’s Bounty Co. is committed to supporting wellness in all its forms.


Job Description  

The Product Vigilance Specialist is responsible for performing select reviews of adverse event data to support QA investigations and aggregate and summarize adverse event data to support product lifecycle contributions for all Nature’s Bounty Co. products. This role will partner with Product Vigilance Specialist team members in the follow up tasks required for timely documentation, assessment, and regulatory reporting of adverse events. The Product Vigilance Specialist supports all internal adverse event data and review requests, as well as the overall performance and initiatives of the Product Vigilance Team. This role will directly report to the Product Vigilance Manager.

Responsibilities include, but are not limited to:

  • Aggregate, scrub, and summarize adverse event data for trending purposes and for use in safety, label, and product improvement initiatives.
  • Perform preliminary review and analysis of select product adverse events, technical data and available scientific literature to support potential hypotheses generation.
  • Conduct hypothesis generation of adverse events for QA investigation GMP compliance.
  • Initiate further product review based on hypothesis or particular event of interest or concern and appropriately escalate findings to Manager.
  • Responsible for all AE data extraction projects and requests from other departments including Nutrition Science, Brand, Consumer Affairs, International Registration, Media, Legal and Quality Assurance.
  • Assist Product Vigilance Specialists in the follow up tasks required for timely review, documentation and assessment of adverse event regulatory reporting.
  • Accurately handle and track submissions to third party pharmacovigilance providers (ProPharma).
  • Advise and support other associates with maintaining case intake compliance with the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSCPA).
  • Maintain working knowledge of nutrients/ingredients and structure function claims.
  • Command of internal procedures and systems used.
  • Perform other duties as assigned.

Qualifications  

  • Relevant work experience required in Regulatory Affairs or Nutrition support role, 3-5 years preferred. Comprehensive industry &/or regulatory knowledge preferred.
  • BS in Nursing/RN or Bachelor’s degree in Nutrition, Pharmacology or other Health Science required.
  • Working knowledge of FDA regulatory requirements.
  • Ability to interpret nutrition research literature and statistical math.
  • Strong organization skills, ability to work independently and meet deadlines.
  • Basic computer skills and proficiency with MS Office (Outlook, Excel, Word).


Additional Information  

The Nature's Bounty Co. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 

The Nature's Bounty Co. offers a competitive salary and a comprehensive benefits package, which includes health and dental plans, voluntary short-term and long-term disability, life insurance, flexible spending accounts, 401(k), tuition reimbursement, generous associate discounts and more! 

Please contact Human Resources at 631-244-2120 if you should need a reasonable accommodation to submit your information for our on-line job postings.