Pharmacovigilance Quality Assurance (PVQA) Specialist Contractor

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.

• 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

• Bachelors Degree
• 3-5 years of relevant work experience in a PV QA related role for a pharmaceutical company (or equivalent combination of Drug Safety and Quality Assurance experience)
• Thorough knowledge of EU Good PharmacoVigilance Practices regulations (GVP)
• Strong knowledge of US and International Safety Reporting requirements
• Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) knowledge an asset

• Experience supporting deviation/CAPA management audits or inspections.
• Strong written and verbal communication skills; ability to collaborate across functions.
• Proficiency in Microsoft Office applications.

Capabilities

• Ability to deliver clear effective communication orally and in writing
• Assumes responsibility for successfully accomplishing work and has proven experience in delivering results
• Ability to work independently as well as in a team environment
• Attentive to the details able to recognize critical attributes steps and functions
• Well-organized able to switch priorities quickly coordinate several tasks at once and make quick informed decisions
• Thrives in an environment with tight deadlines and manages oneself with a sense of initiative and urgency

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.

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.

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