Pharmacovigilance Quality Assurance (PVQA) Specialist Contractor

Overview

The PV Quality Assurance Specialist will provide operational support to the Pharmacovigilance / Patient Safety (PSPV) team in maintaining a compliant global PV system. The role is responsible for reviewing quality system documentation supporting deviation and CAPA management and contributing to inspection readiness activities. The individual will also provide subject matter expertise in Good Pharmacovigilance Practices (GVP) U.S. and international safety reporting requirements and support ongoing quality initiatives within the PV Quality Management System (QMS).

This is a hands-on individual contributor assignment that emphasizes compliance support operational execution and cross-functional collaboration across Clinical Regulatory Safety and QA teams.

Responsibilities

• Reviews the global operational model of the Shionogi pharmacovigilance (PV) system and develops plans to establish a compliant PV system.
• Supports the implementation execution and performance oversight of the Shionogi PV System for clinical and commercial operations.
• Reviews PV related Deviations Quality IssuesCAPA and supports their closure and Effectiveness Checks
• Assists in the preparation of KPIs for PV QMS performance monitoring and Management Oversight.
• Informs stakeholders on GVP / GCP Compliance Issues.
• Supports in ongoing Inspections Readiness efforts and during inspections.
• Reviews Standard Operating Procedures (SOPs) and other documentation and training materials related to GXP Compliance and other applicable requirements.
• Supports implementation of quality related projects as assigned.

Qualifications

Capabilities

Additional Information

The hourly rate position is $48 - $70. Individual pay is determined by several factors which include but are not limited to : job-related skills experience and relevant education or training. The range does not include the comprehensive benefits bonus long-term incentive applicable allowances or any additional compensation that may be associated with this role.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race color religion sex (including pregnancy) marital status national origin age ancestry citizenship disability genetic information status as a disabled veteran a recently separated veteran Active Duty Wartime or Campaign Badge Veterans and Armed Forces Service Medal Veterans or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal state and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are in fact non-discriminatory.

If you are qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling or by sending an email to

Required Experience :

IC

Key Skills

Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration

Employment Type : Contract

Experience : years

Vacancy : 1

Monthly Salary Salary : 48 - 70