Pharmacovigilance Associate: SAE Processing & Safety Data

Piper Companies; Bethesda (MD); In loco; USD 34.000 - 40.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Dental insurance

Vision insurance

401K

Sick leave

Descrizione del lavoro

Piper Companies is seeking a S & P Associate for a clinical research organization in Bethesda, MD. The role focuses on safety data handling, SAE processing, and regulatory compliance within drug/vaccine development workflows.

The position requires a Bachelor’s degree with 1+ year clinical research or safety experience, or a health/science Master’s with internship. A strong knowledge of medical terminology and data management is needed.

Competenze

• Bachelor's degree with 1+ year clinical research or safety experience; or a health/science Master's with internship.
• 1+ year experience in a clinical research environment or bioethics setting.
• Knowledge of medical terminology and familiarity with safety data, drug/vaccine development or clinical trials.

Mansioni

• Manage and process SAEs per project requirements.
• Maintain safety docs, electronic files, and tracking systems; support document control.
• Track and process safety data queries and generate safety reports.
• Process safety narratives; assist with MedDRA coding; QC AE submissions; distribute safety information.

Conoscenze

Clinical research experience

Safety terminology

MedDRA coding

Medical terminology

Data analysis basics

Formazione

Bachelor's degree

Master's degree (health/science)

Strumenti

SPSS

SAS

R

Excel

SharePoint

Microsoft Word

Microsoft Outlook

Descrizione del lavoro

Piper Companies is seeking a S & P Associate for a clinical research organization in Bethesda, MD. The role focuses on safety data handling, SAE processing, and regulatory compliance within drug/vaccine development workflows.

The position requires a Bachelor’s degree with 1+ year clinical research or safety experience, or a health/science Master’s with internship. A strong knowledge of medical terminology and data management is needed.