Safety Specialist

Piper Clinical has an opportunity as a Safety & Pharmacovigilance Specialist with a mid-sized clinical research company in the Bethesda, MD area. You would get the opportunity to support clinical trials and drug safety in the areas of infectious disease and oncology!

Responsibilities for the Safety & Pharmacovigilance Specialist include :

• Document, manage, and report all severe adverse events (SAEs) according to study protocol
• Maintain electronic documentation for case files within the department database
• Track and process data from the pharmaceutical data management system
• Assist in writing reports for the appropriate contracts
• Document and process safety narratives for Investigational New Drug (IND) and Non-IND adverse event cases according to study protocol
• Report and distribute Safety Information for each specific project / trial
• Perform quality checks on Adverse Event (AE) submissions

Qualifications for the Safety & Pharmacovigilance Specialist include :

Compensation for the Safety & Pharmacovigilance Specialist includes :

This job is open for applications on 1 / 31 / 2025. Applications will be accepted at least 30 days from the posting date.

Safety, pharmacovigilance, pharmacology, pharmacy, pharmaceutical, pharma, clinical research, clinical trials, clinical research organization, contract research organization, cro, oncology, infectious disease, cardiovascular, protocol, standard operating procedures, sops, severe adverse events, saes, adverse events, aes, investigational new drug, ind, non-ind, fda, food and drug administration, investigational review board, irb, regulatory, compliance, bioethics, doctor of pharmacy, pharmd, doctor of philosophy, phd, medical doctor, md, ecfmg, fcgep, pharmacist, doctor, redcap, medidata, epic, oncore, rave, spss, data analysis, data reporting, data, good clinical practices, gcp, ethics, ethical

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Salary : $70,000 - $95,000