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Pharmacovigilance Specialist

Manages patient safety of clinical trials. Prepares and reviews all safety guidelines, establishes workflow and procedural manuals, conducts safety training, manages reporting documents, adverse event case reports, personal data and safety databases, operates the Medical Safety Review Committee and coordinates with clients as necessary.

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Project Manager (DSMA – Drug Safety and Medical Affairs)

Supports clients in the post-marketing phase of Phase IIIb and IV clinical projects. Works alongside the Project Coordination Center and other departments.

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QA Auditor

Plans, conducts and reports quality assurance audits. Ensures quality and compliance with regulations, guidelines and corporate policies of clients and Quintiles. Conducts independent audits of projects and processes.

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Regulatory Affairs

Prepares and reviews regulatory submissions to support clinical trials and/or marketing activities for both internal and external clients. Provides regulatory strategy to support clinical trial and marketing authorization activities for internal and external clients.

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