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
Scientist • Eugene, Oregon, United States