Senior Drug Safety Physician

Company Overview

At Parexel, our shared goal is to improve the world's health. From clinical trials to regulatory consulting and market access, every clinical development solution we provide is underpinned by a deep conviction in what we do. Each of us contributes to the development of therapies that ultimately benefit patients. We take our work personally, perform with empathy, and are committed to making a difference.

Responsibilities

Perform medical review of literature references in accordance with client procedures, SOPs, and regulatory guidelines for product safety assessment.

Conduct signal detection, analysis, evaluation, and ongoing safety surveillance activities.

Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists on medical aspects of drug safety.

Review and provide medical, safety input on all required safety reports, including but not limited to:

Periodic Safety Update Reports (PSURs)
Periodic Benefit Risk Assessment Reports (PBRERs)
Periodic Adverse Drug Experience Reports (PADERS)
Risk Management Plans (RMPs)
Benefit Risk Assessment
Signal Evaluation Reports (SERs)
Clinical Overview (COs)
Clinical Expert Statements
Investigator notification letters

Author and review aggregate reports for medical context and consistency per client requirements and SOPs.

Provide medical advice to case processors for authoring sections.

Train and mentor new team members as required.

Serve as a Subject Matter Expert (SME).

Assist the Manager, DSP, with inspection readiness activities and audits.

Provide inputs for process improvements.

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