Job Description

Piper Companies is hiring a Safety & Pharmacovigilance Specialist to support clinical research and ensure regulatory compliance in the reporting and analysis of adverse events. This position is hybrid and requires experience in drug development and clinical trials.

Responsibilities for the Safety & Pharmacovigilance Specialist include:

• Ensure compliance with Standard Operating Procedures (SOPS) and global regulations for adverse event reporting.
• Develop and process adverse event reports, providing medical evaluations of adverse event reports as required.
• Maintain and update agent-specific clinical and preclinical toxicity summary tables.
• Conduct literature searches related to safety and pharmacovigilance to prepare, review, and edit safety-related presentations.
• Perform adverse event analysis and serious adverse event reconciliation.
• Prepare IND safety reports for FDA submission and conduct safety data analysis.
• Provide clinical trial site support for adverse event reporting and resolution.
• Assist in preparing safety updates for NDAs, INDs, investigator communications, product labeling, and package inserts.
• Review experimental protocols and informed consent documents.

Qualifications for the Safety & Pharmacovigilance Specialist include:

• Medical degree (MD, ECFMG) is required.
• 2+ years of experience in academic, pharmaceutical, or biotech industry settings.
• Knowledge of GCP and ICH guidelines preferred.
• Experience in drug development and clinical trials.
• Familiarity with safety databases and MedDRA coding preferred.

Compensation for the Safety & Pharmacovigilance Specialist includes:

• Salary: $75,000 - $100,000 annually, commensurate with years of experience
• Comprehensive Benefits: Medical, Dental, Vision, 401k, PTO, Sick leave as required by law

This job opens for applications on 9/22/2025. Applications will be accepted for at least 30 days from the posting date.

Keywords: Safety Specialist, Pharmacovigilance, adverse event reporting, IND safety reports, FDA compliance, WHO regulations, drug development, clinical trials, MedDRA, GCP, ICH, NDA safety updates, toxicity tables, serious adverse event, SAE, safety data analysis, regulatory affairs, biotech, pharmaceutical safety, drug safety, pv, md, medical doctor, ecfmg, doctor of medicine

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Job Tags

Full time,

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