Quality and Compliance Specialists

6 months ago

Malvern, United Kingdom Zoetis Full time

ROLE DESCRIPTION:
Zoetis is a global animal health company dedicated to supporting customers and their businesses. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.

:
The Quality and Compliance Specialist protects Zoetis assets by assuring compliance and quality of case data in accordance with FDA and USDA reporting regulations, existing documentation, and internal procedures, supporting the Contact Centers responsible for pharmacovigilance reporting. 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 Service Cloud by Contact Center 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, and those that need approval.
- 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.
- Conduct regulatory training of departmental staff, contractors and external vendors as requested.
- Participate with activities that ensure audit-readiness, including timely SOP reviews and updating, creating and retiring SOPs, take part in internal inspections.
- Collaboratively work with and respond to internal Regulatory Affairs requests.
- Participate in regulatory/compliance related discussions, including but not limited to staff meetings, Clinical Forums, VMIPS-VMRD-PV and Team meetings.
- Conduct colleague training on new and updated case handling and pharmacovigilance/agency guidelines.
- Maintain familiarity with veterinary practice operations and terminology.
- Awareness of documented agency regulations and guidelines (CFR, GFI and VICH).
- Maintain knowledge of BU processes and working practices.
- Maintain collegial, team-player attitude when interacting with Customer Care colleagues.

ORGANIZATIONAL RELATIONSHIPS:

- Veterinary Medical Information and Product Support contact center personnel (Technicians, Veterinarians, Managers)
- Veterinary Medical Research and Development (VMRD) Global Regulatory Affairs-Pharmacovigilance
- Customer Care Contact Center (Veterinary Customer Service, Global Diagnostic, Zoetis Reference Labs Customer Service)

EDUCATON 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 think critically and use own judgement with confidence.
- Ability to work as a team member as well as independently.
- Have a passion for compliance.
- Be able to coach and training others.
- Excellent verbal, written, and interpersonal communication skills.
- 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 work with people at all levels, and personalities, 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
- Ability to work rotating shifts, Monday through Friday, with core hours of 8am-6:30pm
- Travel into local office

Full time

Regular

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