What are the responsibilities and job description for the Safety & Pharmacovigilance Specialist I position at Piper Companies?
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:
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
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
- 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
- Rate Range: $70,000-$100,00 (dependent on experience)
- Comprehensive Benefit Package: Medical/Dental/Vision, 401K, Sick Leave as Required by Law
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