Piper Companies is currently searching for a Safety and Pharmacovigilance Associate for a full service, biopharmaceutical CRO in Bethesda, MD.

Responsibilities of the Safety and Pharmacovigilance Associate include:

• Manage and process all SAEs (Serious Adverse Event) per specific projects instructions
• Perform document control: maintain files, perform file case searches, maintain file room for department and department database, manage and control issued documents, assign various tracking numbers
• Assist with the preparation of contractual reports
• Process and revise safety narratives for IND and Non-IND SAEs
• Share Safety Information regarding project specific requirements to department

Qualifications of the Safety and Pharmacovigilance Associate include:

• 1+ years of experience in a clinical research environment
• Data management experience
• Knowledge of medical terminology is a plus
• Master's degree in Science related field

Benefits of the Safety and Pharmacovigilance Associate include:

• Salary up to $55,000, commensurate with experience
• Full benefits: Medical, Vision, Dental and 401k

Keywords:

Safety, pharmacovigilance, SAE, AE, serious adverse event, adverse event, CRO, Clinical research organization, clinical trials, pharmaceutical, biotechnology, biotech, gcp, good clinical practices, qms, quality management system, quality management plans, cqms, sop, standard operating procedures, protocol, quality assurance, qa, capa, investigations, audit, certified quality assurance auditor, CQA, clinical information, CIS, Clinical information specialist, Clinical Research Ethicist, HPS, human protection, clinical trial safety, human subject protection, GCP, IRB, international review board, FDA, pharmacology, toxicology, biochemistry, infectious disease, IND, investigational new drug.

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