JOB DESCRIPTION

Position: Safety Data Scientist (REMOTE)

Employment Type: 12 months contract

Location: Fort Washington, PA 19034

About ClinChoice

ClinChoice is a clinical stage CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across US, China, Europe, India, Japan and the Philippines. It has over 1,800 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.

Job Description

Familiarity with qualitative and quantitative signal detection methods

Robust medical interpretation of safety data with oversight

• Analyze and interpret data from multiple sources (clinical trials, safety databases, literature, etc).
• Utilizes medical judgment to determine the impact of the safety issue on the product’s benefit-risk profile
• Lead authoring of assessment for identified signals

Ability to interpret, summarize and present clinical data and other complex information in written and oral presentations to leadership and safety governance.

Application of thorough understanding of FDA and ICH regulations and guidelines to independently strategize, author and review safety deliverables

Quickly and comprehensively learn and understand

• Company standard operating procedures
• Assigned products/therapeutic areas
• Safety profile (labeling, literature, clinical and regulatory issues)
• Required systems and tools

Education: Masters or doctorate + 4-5 years clinical/pharma or safety work experience (e.g. MPH, PharmD, PhD, or Masters in a Health Science)

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ClinChoice is an Equal Opportunity Employer / Committed to Diversity