Pharmacovigilance Quality Assurance Specialist – Contractor

8 hours ago

🏖️ New Jersey – Remote

Although this job is listed in New Jersey, this company may be open to hiring remote in other states.

💵 $48 - $70 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Shionogi Inc. (U.S.)

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Shionogi Inc. (U. S. ) is a pharmaceutical company committed to improving patient lives by developing innovative treatments for challenging diseases. Since its establishment in 1878, Shionogi has focused on addressing global health issues such as antimicrobial resistance and COVID-19, with a strong emphasis on research and development of novel antibiotics and antiviral medications. The company prioritizes scientific excellence and collaboration with various partners to advance healthcare solutions.

501 - 1000 employees

Founded 2001

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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 Issues, CAPA, 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.

🎯 Requirements

• Bachelor's 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.