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Associate Director, PVQA Palo Alto United States,  


Posted on : 13 June 2017

Project Description

The Associate Director of Pharmacovigilance Quality Assurance is responsible for execution of the PV quality program. Key responsibilities include but are not limited to: providing GVP consultation to pharmacovigilance teams, investigating and documenting PV related quality issues, facilitating CAPA development, developing or contributing to GxP training to business partners, supporting health authority inspections, performing quality reviews/audits of safety related submission documents, conducting or supporting applicable GVP related audits, and performing inspection readiness activities. Essential Functions Plans, schedules, conducts, reports, and follows up on PV related audits as assignedCommunicates audit and quality issue investigation outcomes and monitors compliance to regulations and internal proceduresPartners with Pharmcovigilance and other R&D functions as appropriate to develop effective corrective actions and preventative actions (CAPAs) to ensure continuous improvementApproves CAPAs and reviews for effectiveness. Responsible for maintaining evidence record in support of inspection readinessContributes to the presentation of key quality performance indicators and othe metrics as assignedProvides GVP consultation to R&D business partnersEvaluates R&D systems for optimization and continuous improvementParticipates in the development, review and approval of standard operating proceduresAssists with inspection readiness, preparation, and execution activities as assignedRequired Knowledge, Skills, and Abilities Minimum 10 years pharmaceutical or biotechnology industry experience, including at least 3 years in PharmacovigilanceGVP experience required, GCP, GLP, GMP preferred Required/Preferred Education and LicensesBachelor’s Degree in Business or Life sciences is required, advance degree is preferredASQ certification or equivalent is preferred Description of Physical DemandsOccasional mobility within office environment.Routinely sitting for extended periods of time.Constantly operating a computer, printer, telephone and other similar office machinery. Description of Work EnvironmentWork indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.Frequent computer use at workstation.May move from one work location to another occasionally.Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.Occasional public contact requiring appropriate business apparel. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.

Locations

Palo Alto California

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