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Compliance Specialist

Palo Alto, CA 94304

Posted: 01/25/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 542944 Is job remote?: Yes Country: United States

Job Description

Brief Description:
Pay rate range: $50-60/hr

This role works in the PV Compliance (PVC) team within the Global Pharmacovigilance and Labelling department. The role will report to the Associate Director, PV Quality & Compliance and is responsible for performing administrative compliance activities across different datasets that have a pharmacovigilance or patient safety touchpoint. Dataset examples include but are not limited to, individual case safety report (ICSR) data, risk evaluation mitigation strategy data, regulatory information management data. This role will reconcile compliance-related investigations on ICSRs to ensure data integrity and track action items.
Additional responsibilities may include maintenance of pharmacovigilance compliance activities and support with metrics.

Essential Functions
• Review and reconcile outcomes of quality control (QC) activities to ensure complete and accurate information is in the relevant databases such as The Global Safety Database, Intake Safety System, PVC Late Logs and Quality Management System.
• Review and reconcile compliance-related investigations on ICSRs to ensure complete and accurate assessments of responsible parties, root cause and corrective/preventative action plans.
• Prepare feedback summary reports to share with the business.
• PV compliance focused support of Quality Management System records.
• Support PV Compliance and alliance activities.
• Remain current with global pharmacovigilance regulations and requirements.

Required Knowledge, Skills, and Abilities
• Minimum 1 year business, pharmaceutical, or biotechnology industry experience
• Can apply base level quality control technical concepts and skills
• Developing written and verbal communications skills
• Ability to work in a fast-paced environment
• Individual contributor with oversight from line manager
• Ability to work across geographical boundaries
• Disciplined, detail oriented, and good time management skills

Required/Preferred Education and Licenses
• Bachelor’s degree in business or life sciences required
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