Safety & Pharmacovigilance Associate

Piper Companies; Bethesda (MD); Hybrid; USD 34,000 - 40,000; Full time

Benefits offered by this job

Medical/Dental/Vision insurance

401K

Sick leave

Job summary

Piper Companies is seeking an S & P Associate to join a clinical research organization in Bethesda, MD. The role focuses on safety data management, SAE processing, and documentation control within a hybrid work model.

The position requires a life sciences background with relevant internship experience and at least 1 year in clinical research or safety. It offers a competitive hourly rate and comprehensive benefits in a regulated, collaborative environment.

Qualifications

• Bachelor's degree with 1+ years of clinical research or safety experience
• 1+ years of experience in a clinical research environment or bioethics setting
• Knowledge of medical terminology and drug/vaccine development process or clinical trials

Responsibilities

• Manage and process Serious Adverse Events (SAEs) per project requirements.
• Maintain safety documentation, electronic files, and tracking systems.
• Track and process DMC queries and generate safety data reports.
• Process safety narratives, assist with MedDRA coding, QC AE submissions, and distribute safety information.

Skills

Clinical research

Safety data analysis

Regulatory compliance

Education

Bachelor's degree in life sciences

Master's degree in life sciences (with internship)

Tools

SAS

SPSS

Microsoft Excel

Microsoft Word

SharePoint

Job description

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

This job is open for applications on August 4th, 2026. Applications will be accepted at least 30 days from the posting date.

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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