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:

• Master's/Medical Degree required.
• 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 9/17/2025. Applications for this job will be accepted for at least 30 days from the posting date.

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Job Tags

Full time,

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