Pharmacovigilance Scientist

Job Summary

A company is looking for a Pharmacovigilance Scientist (PV).

Key Responsibilities:

• Support quality control review of individual case safety reports (ICSRs) for accuracy and compliance
• Conduct signal detection activities and analyze data to identify potential safety signals
• Contribute to the preparation of safety documentation for NDA submissions and assist during audits

Qualifications:

• Bachelor's Degree in biologic or natural science, or health care discipline; advanced degree preferred
• Minimum of 3 years of Pharmacovigilance experience, including aggregate safety reports and signal management
• Strong foundation in Pharmacovigilance and drug development regulations
• Knowledge of US and EU pharmacovigilance regulatory requirements
• Expertise in safety data analysis and signal management