Senior Safety Associate

ByHeart

ByHeart

New York, NY, USA
Posted on Sunday, September 10, 2023

ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That’s why we studied the latest breast milk science, worked directly with suppliers we know and trust, set uncompromising quality standards, developed our own small batch blending process, built our own manufacturing facilities, and conducted a groundbreaking clinical trial. Our goal is to create a future where all parents feel amazing about feeding their baby—no matter how they do it.

When we launched our Whole Nutrition Infant Formula in March 2022, we were the first new U.S infant formula manufacturer in 15 years. Since then, we’ve been leading the way in a lot of ways.

We’re…

  • The only U.S.-made infant formula to use organic, grass-fed whole milk
  • The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk—alpha-lac and lactoferrin—to our ingredients list
  • The first infant formula company to receive Clean Label Project’s Purity Award (and we test for 700 contaminants vs the required 400)
  • We ran the largest clinical trial by a new infant formula brand in 25 years—clinically proving our benefits vs a leading infant formula like:
    • Less spit up
    • Softer poops
    • Easier digestion
    • More efficient weight gain
    • Enhanced nutrient absorption
    • Longer stretches between nighttime feeds*

With >$250M in funding, we’re shifting the industry forward—and this is just the beginning. Help us build a future where all parents can feel amazing about feeding, by joining our growing team of >275 people that stretches across the country.


We're proud to offer competitive, family-first benefits, including but not limited to:

  1. Health insurance for the whole family: medical, dental, & vision insurance covered 100%, with 90% coverage for your family.
  2. Flexible paid time off: plus 12+ company holidays, and your kid’s birthday off!
  3. 16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time.
  4. Up to 6% 401(k) Match to help you plan for your future.
  5. Company equity for every employee: because when we succeed, we succeed together!

Visit our site to learn more, and check out some recent press on ByHeart:

*based on data from infants at approximately 4 months of age


Role Description

Reports To: Director of Pharmacovigilance

Location: New York City or Remote

Start Date: Immediate

Role Responsibilities

  • Perform intake review and data entry of all product health-related complaints in an expeditious manner into the complaint management system (CMS).
  • Write individual case safety report (ICSR) narratives.
  • Interpret reported health concern information, including medical conditions, laboratory tests, healthcare provider evaluation, and treatment.
  • Capture complaint codes utilizing MedDRA coding.
  • Examine complaint records for sufficient information to complete evaluation before forwarding the complaint record for medical review.
  • Maintain knowledge of common pregnancy, infancy, and toddler diagnoses, as well as disease pathology and physiology.
  • Adhere to department specific standard operating procedures (SOPs) and guidelines.
  • Aid in continued process improvement of health-related complaint review procedures, workflows, and templates.

Skills & Qualifications

  • Nutrition science and/or healthcare background required.
  • BA/BS and/or relevant medical/clinical job experience required.
  • Minimum 1 year experience in handling of complaints required.
  • Previous experience with product safety systems or complaint management system preferred. Proficient with MS Office, and able to utilize various applications and electronic databases with minimal input.
  • Strong knowledge of industry acronyms and medical terminology required.
  • Demonstrate collaborative skills, meticulous attention to details, and the ability to work with minimal supervision.
  • Ability to travel domestically 5-10 % of the time.

The minimum annual salary for this position is $83,000 and the maximum is $100,000. The salary range for performing this role outside of New York City will differ. Additionally, you will be eligible for a discretionary performance based annual cash bonus and to participate in our company’s equity program, plus our robust medical, dental, vision, retirement, and other benefits.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.