Safety & Pharmacovigilance Associate - 171898

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 looking for a S & P Associate to join a clinical research organization located in Bethesda, MD.

Responsibilities of the S & P Associate include:

• Manage and process Serious Adverse Events (SAEs) in accordance with project-specific requirements.
• Maintain and organize safety documentation, electronic files, and tracking systems while supporting document control activities.
• Track and process pharmaceutical and Data Management Center (DMC) queries and generate requested safety data reports.
• Process safety narratives, assist with MedDRA coding activities, perform quality control reviews on AE submissions, and distribute safety information as required.

Qualifications for the S & P Associate include:

• Bachelor's degree with at least 1+ years of clinical research or safety experience, or a scientific/health-related Master's degree with relevant internship experience.
• 1+ years of experience in a clinical research environment or bioethics setting.
• Knowledge of medical terminology and familiarity with medical research data, experimental protocol review, safety data summarization, and the drug/vaccine development process or clinical trials.

Compensation for S & P Associate includes:

• Rate Range: $25-$29/ hr, depending on experience
• Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

Keywords:Drug Safety, Pharmacovigilance, Safety Operations, Serious Adverse Events (SAEs), Adverse Events (AEs), SAE Processing, Case Processing, Safety Narratives, IND Cases, Non-IND Cases, MedDRA Coding, AE Reconciliation, Safety Database Management, Safety Reporting, Clinical Safety, Regulatory Compliance, GCP, ICH Guidelines, FDA Regulations, Clinical Research, Clinical Trials, Drug Development, Vaccine Development, Safety Surveillance, Signal Detection, Data Management, Data Analysis, Data Quality Control, QC Review, DMC Queries, Medical Terminology, Medical Research Data, Safety Documentation, Document Control, Regulatory Submissions, Site Communications, Safety Communications, Safety Distributions, Medical Monitoring Support, Protocol Review, Safety Data Review, Electronic File Management, SharePoint, Microsoft Excel, Microsoft Word, Microsoft Outlook, SPSS, SAS, R, Clinical Operations, Research Compliance, Biomedical Research, Life Sciences, Healthcare Research, Case Tracking, Report Generation, Pharmacovigilance Operations

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