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(Archived) Quality and Compliance Specialist

Last Updated: 11/28/21

Job Description

POSITION SUMMARY

The Veterinary Medical Information and Product Support (VMIPS) Team fosters the safe and appropriate use of Zoetis products with all customer segments and all approved contact center channels by responding to unsolicited requests for medical and technical information. VMIPS is responsible for maintaining the regulatory integrity of our growing product portfolio by identifying and appropriately completing regulatory reportable cases. VMIPS does all of this with a customer obsessed mindset with the goal of providing outstanding customer service to our customers.

The Quality and Compliance Specialist (QAS) protects Zoetis assets by assuring compliance and quality of VMIPS data in accordance with FDA and USDA reporting regulations, existing documentation and internal procedures. The Quality and Compliance Specialist is responsible for the review and auditing of regulatory cases associated with reported product adverse experiences documented in a pharmacovigilance database, assuring regulatory reporting standards are maintained.

POSITION RESPONSIBILITIES

  • Conduct daily quality review of cases documented in the pharmacovigilance database by VMIPS case owners, associated with reported adverse experiences to ensure accuracy, timely submission, and compliance with current pharmacovigilance (PV) and SOP requirements
  • Run daily and ad-hoc reports to: identify cases to be quality reviewed, conduct trending analysis, identify cases that have not been approved, etc.
  • Provide timely feedback to case owners and follow-up when case corrections are requested
  • Respond to case owner questions on regulatory guidelines, case completion and relevant practices
  • Proactively look for and suggest improvements to current regulatory processes, including all pertinent working practices; work with manager to implement efficiencies to the case management process (data entry, medical investigation, customer responses and case follow-up)
  • Conduct regulatory training of departmental staff, contractors and external vendors as requested
  • As part of the VMIPS Audit Team, perform duties specific to ensuring VMIPS remains audit-ready, including timely SOP reviews and updating, creating and retiring SOPs, take part in internal inspections
  • Assist with development of KPIs
  • Collaboratively work with and respond to VMRD-PV and GMS colleague requests
  • Participate in regulatory/compliance related discussions, including but not limited to staff meetings, Clinical Forums, VMIPS-VMRD-PV and Team meetings
  • Maintain familiarity with veterinary practice operations and terminology
  • Awareness of documented agency regulations and guidelines (CFR, GFI and VICH
  • Remain fluid with the use of PV Works and provide training to colleagues, serving as a subject matter expert
  • Maintain knowledge of VMIPS processes and working practices
  • Maintain collegial, team-player attitude when interacting with VMIPS colleagues
  • Complete ongoing required training within stipulated time-frames in order to maintain strong knowledge of products, programs, policies and procedures
  • Participate in ongoing departmental and weekly team meetings
  • Manage multiple tasks simultaneously in a consistently changing environment
  • Exemplify the Zoetis Values: Our colleagues make the difference, Always do the right thing, Customer Obsessed, Run it like you own it, We are one Zoetis
  • Perform other duties as requested by Manager

EDUCATION AND EXPERIENCE

  • Bachelor’s degree preferably in Animal Science or Regulatory discipline or
  • CVT with at least three years relevant experience in an equivalent field and, or regulatory environment

TECHNICAL SKILLS REQUIREMENTS.

  • Highly detail-oriented approach to work
  • Must be self-motivated and disciplined
  • Ability to work independently and as a team member
  • Excellent verbal, written, and interpersonal communication skills
  • Excellent computer skills including proficiency in Microsoft Office applications
  • Flexibility and ability to handle multiple tasks simultaneously
  • Ability to display high levels of initiative, effort, and commitment in order to successfully complete projects and assignments
  • Must be able to influence without authority
  • Must be able to deal with people at all levels inside and outside of the company
  • Must be able to successfully complete training and meet training expectations in order to proceed to servicing Zoetis

PHYSICAL POSITION REQUIREMENTS

  • Sitting
  • Standing
  • Occasional Travel
  • Ability to work rotating shifts, Monday through Friday, including some evenings and holidays

Full time

Regular

Colleague

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [Register to View] to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of [Register to View] In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Company Details

Parsippany, New Jersey, United States
Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.