Share this Job

Analyst - Post-Market Surveillance

Location: 

Milford, CT, US

Req ID:  507
Job Type: 

We are a global team of 6000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.

 

Open to having new Employee working in Allendale NJ, Shelton CT, Milford CT, or Ormond Beach FL.

 

Position Summary:

 

  • Responsible for reviewing and investigating all consumer insights for products manufactured and distributed by Edgewell as required by applicable regulations, standards, and company policy.  Works closely with Global Technical Operations (GTO) experts throughout the organization to resolve product concerns.

 

Accountabilities

 

  • Works on issues of complex scope and risk where analysis of situation or data requires an in-depth evaluation of a variety of factors.  Exercises judgment within defined procedures and practices to determine appropriate action
  • Performs data queries and conducts statistical analysis on data sets for trending, interpret results, and escalate issues to key stake holders as necessary
  • Ensures the timely closure of all assigned product issues in a consistent and timely manner, and documents investigation findings and associated activities in accordance with policies and procedures
  • Interfaces with Consumer Affairs to ensure data integrity and to gather additional information required for complaint investigations, including the retrieval of consumer samples for evaluation
  • Partners with pharmacovigilance resources on any possible adverse event or reportable complaints, and informs when quality investigation has been completed
  • Creates monthly and quarterly consumer complaint data reports and facilitates cross-functional review meetings
  • Completes all assigned continuous learning assignments timely in the Learning Management System
  • Monitors and reports on complaint metrics as required to manager
  • Ensures readiness and compliance for regulatory inspections and represents Post Market Surveillance in audits and inspections when required
  • Responsible for SOP revisions/document creation/annual document review as assigned
  • Builds global collaborative working relationships
  • Contributes to team effort by accomplishing related tasks as needed

 

Required Education, Skills and Experience

 

  • Bachelor’s degree in a technical field (for example Quality Engineering, Data Science, Epidemiology, Public Health) required
  • Minimum 3 years of related business experience with understanding of drug/device/cosmetic/consumer product safety requirements strongly preferred
  • Demonstrates critical thinking, strong decision making and problem-solving skills.
  • Demonstrated analytical capabilities with the ability to perform and automate data analysis (graphs, charts, pivot, statistics etc.)
  • Excellent interpersonal skills, with ability to interact/communicate effectively across various levels within the organization
  • Experience in creating/editing work instructions/procedures
  • CAPA and non-conformance experience preferred
  • Ability to work independently with little supervision; self-motivation is a must
  • Ability to effectively prioritize and manage multiple activities and responsibilities
  • Ability to maintain a high level of confidentiality and professionalism
  • Excellent computer skills – Microsoft Office

 

 

Desirable Education, Skills and Experience

  • SAP experience, a plus
  • Ability and willingness to travel, as in the execution of the duties of this position, the employee may travel up to approximately 10% of their work time

 

Environmental, Health and Safety Responsibilities (if applicable)

  • Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
  • Perform every job safely, for the benefit of self, co-workers, contractors, and for the protection of facilities. This includes the use of required personal protective equipment and use of safety equipment as well as safe work practices.
  • Immediately report every job-related injury or illness, regardless of severity, to a supervisor.
  • Assist in investigating incidents as directed by your supervisor.
  • Take necessary actions to correct or stop any unsafe conditions or practices.
  • Actively participate in safety meetings and training.

 

Work Environment

 

  • Ability to walk and stand for long periods of time
  • Ability to travel – ground and air

 

Edgewell is an equal opportunity employer, and we prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.

 

#LI-JM1

*CB*

 

 


Nearest Major Market: New Haven
Nearest Secondary Market: Hartford