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
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