Safety & Pharmacovigilance Specialist I — Clinical Trials

Piper Companies; Bethesda (MD); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical/Dental/Vision

401K

Sick Leave as Required by Law

Job summary

Piper Companies in Bethesda, MD seeks a Safety & Pharmacovigilance Specialist I to join our clinical research team on-site. You will ensure FDA/ICH compliance and manage adverse event reporting for marketed and investigational drugs, performing medical evaluations and safety data analysis.

Strong communication and team collaboration are essential. Ideal candidates have at least 2 years in pharma/biotech, familiarity with MedDRA coding and safety databases, and the ability to support regulatory

Qualifications

• Familiarity with GCP and ICH guidelines; experience in drug development and clinical trials required.
• Knowledge of safety databases and MedDRA coding preferred
• Experience leading clinical or cross-functional teams is a plus
• Strong oral, written, presentation, and computer skills
• Minimum of 2 years in academic, pharmaceutical, or biotech settings

Responsibilities

• Ensure compliance with FDA, WHO, and global regulatory standards for adverse event reporting
• Manage consistent and timely processing of adverse event reports
• Conduct medical evaluations of reported adverse events
• Support clinical research activities for both marketed and investigational drugs, including adverse event reporting and analysis
• Maintain and update toxicity summary tables for investigational agents
• Perform literature reviews and safety data analysis
• Prepare IND safety reports and assist with NDA safety updates, investigator communications, and product labeling
• Review experimental protocols and informed consent documents; contribute to safety-related presentations

Skills

GCP & ICH guidelines

Oral communication

Written communication

Presentation skills

Computer skills

MedDRA coding

Safety databases

Team leadership (plus)

Tools

MedDRA

Safety databases

Job description

Piper Companies is looking for a Safety & Pharmacovigilance Specialist I to join a clinical research organization located in Bethesda, MD.

Responsibilities of the Safety & Pharmacovigilance Specialist I include:

· Ensure compliance with FDA, WHO, and global regulatory standards for adverse event reporting

· Manage consistent and timely processing of adverse event reports

· Conduct medical evaluations of reported adverse events

· Support clinical research activities for both marketed and investigational drugs, including adverse event reporting and analysis

· Maintain and update toxicity summary tables for investigational agents

· Perform literature reviews and safety data analysis

· Prepare IND safety reports and assist with NDA safety updates, investigator communications, and product labeling

· Review experimental protocols and informed consent documents; contribute to safety-related presentations

Qualifications for the Safety & Pharmacovigilance Specialist I include:

· Familiarity with GCP and ICH guidelines; experience in drug development and clinical trials required

· Knowledge of safety databases and MedDRA coding preferred

· Experience leading clinical or cross-functional teams is a plus

· Strong oral, written, presentation, and computer skills

· Minimum of 2 years in academic, pharmaceutical, or biotech settings

Compensation for Safety & Pharmacovigilance Specialist I includes:

· Rate Range: $70,000-$100,00+(dependent on experience)

· Comprehensive Benefit Package: Medical/Dental/Vision, 401K, Sick Leave as Required by Law

This job is open for applications on August 27th, 2026. Applications will be accepted at least 30 days from the posting date.

Keywords:

Safety & Pharmacovigilance, Adverse Event Reporting, Serious Adverse Event Reconciliation, IND Safety Reports, NDA Safety Updates, Clinical Trial Support, FDA Regulations, WHO Guidelines, Global Regulatory Compliance, GCP, ICH, MedDRA Coding, Safety Data Analysis, Literature Review, Toxicity Summary Tables, Investigator Communication, Protocol Review, Informed Consent Documents, Drug Development, Clinical Research, Biotech, Pharmaceutical, Safety Databases, Signal Detection, Risk Management Plans, Case Narrative Writing, Regulatory Submissions, Benefit-Risk Assessment, Safety Surveillance, Pharmacovigilance Systems

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