Job Description

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 GCP 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, PTO, Sick Leave as required by Law, and holidays

Keywords: drug safety, pv, pharmacovigilance, safety specialist, medical monitor, medical review, medical reviewer, medDRA, GCP, ICH, SAE, severe adverse events, adverse events, AE, IND, safety data, MBBS, ECFMG, clinical trial, drug application safety, medical evaluation, clinical research, Regulatory associate, CRO, safety database, drug development, who-dd, ICSR, case processing, Safety Surveillance, SAE Reconciliation, Regulatory Compliance, patient safety, clinical data

#LI-JA2 #LI-HYBRID

This job opens for applications on February 7, 2025. Applications for this job will be accepted for at least 30 days from the posting date. Piper Companies

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