Job Description

Piper Companies is seeking a Safety & Pharmacovigilance (S&P) Specialist to join a dynamic team in Bethesda, MD. This role is ideal for professionals with a strong background in clinical research and drug safety who are passionate about ensuring regulatory compliance and supporting the development of investigational and marketed drugs. MASTER'S/MEDICAL DEGREE REQUIRED (foreign MD accepted).

Responsibilities for the Safety & Pharmacovigilance (S&P) Specialist Includes:

• Ensure compliance with TRI SOPs, FDA, WHO, and global regulations for adverse event reporting.
• Develop and manage uniform, timely processing of adverse event reports.
• Provide medical evaluation of adverse event reports.
• Support clinical research activities including reporting, collecting, and sharing adverse event data.
• Maintain and update toxicity summary tables for investigational agents.
• Conduct literature searches related to drug safety and efficacy.
• Analyze and process adverse events; reconcile serious adverse events.
• Prepare IND safety reports for FDA submission and conduct safety data analysis.
• Provide clinical trial site support and manage safety communications.
• Assist in preparing NDA safety updates, IND safety reports, investigator communications, product labeling, and other regulatory documents.
• Review experimental protocols and informed consent documents; prepare and edit safety-related presentations.

Qualifications for the Safety & Pharmacovigilance (S&P) Specialist Includes:

• Medical Degree required - accepting both foreign and domestic ( Ph.D. not accepted)
• Minimum 2 years of experience in academic, pharmaceutical, or biotech industry.
• Strong knowledge of GCP and ICH guidelines; clinical trial experience essential.
• Familiarity with safety databases and MedDRA coding preferred.
• Experience leading clinical and cross-functional teams is a plus.
• Excellent oral, written, presentation, and computer skills.

Compensation for the Safety & Pharmacovigilance (S&P) Specialist Includes:

• Salary Range: $70,000.00 - $85,000.00 annually, depending on experience and certifications
• Comprehensive Benefits: CIGNA Medical, Dental, Vision; 401K through ADP

This job opens for applications on 10/3/2025. Applications for this job will be accepted for at least 30 days from the posting date.

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keywords: Clinical Research Specialist, Drug Safety Associate, Pharmacovigilance Specialist, Clinical Trials Coordinator, Regulatory Affairs Associate, Medical Safety Officer, Clinical Safety Scientist, Adverse Event Analyst, IND Safety Specialist, Clinical Data Reviewer, Clinical Research Associate, Safety Reporting Specialist, Biotech Safety Analyst, FDA Compliance Specialist, Clinical Risk Manager, Clinical Development Specialist, Medical Affairs Associate, Toxicology Analyst, Clinical Operations Specialist, Clinical Documentation Specialist, Clinical Study Coordinator, Clinical Monitoring Specialist, Clinical Quality Assurance Analyst, Clinical Research Scientist, Clinical Project Manager

Job Tags

Full time,

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