Medical Reviewer

Piper Health Sciences is seeking a Safety & Pharmacovigilance Associate (Hybrid) to join a clinical research and pharmaceutical company in Bethesda, MD. The Safety & Pharmacovigilance Associate (Hybrid) will assist with severe adverse event reporting.

Responsibilities for the Safety & Pharmacovigilance Associate (Hybrid):

• Ensure compliance and regulations for the reporting of adverse events
• Process adverse events on time
• Report, collect, and share results and issues around adverse event reports for currently marketed drugs and those in the experimental stages of development
• Prepare IND safety reports for submission to the FDA
• Assist with new drug application safety reports and other reports as necessary

Requirements for the Safety & Pharmacovigilance Associate (Hybrid):

• 2 years of experience
• Experience with SAE reporting
• Knowledge of Google Cloud Platform and ICH guidelines preferred;
• Previous experience with clinical trials
• Experience with MedDRA coding

Compensation for the Safety & Pharmacovigilance Associate (Hybrid):

• Salary Range: $70,000 - $100,000 **depending on experience**
• Full Benefits : Cigna Medical/Dental/Vision, 401k, hybrid

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