Senior Benefit/Risk Associate
Core
Performing and supporting contracted pharmacovigilance activities, specifically signal detection, evaluation, and reporting to ensure patient safety.
Role type
Senior Benefit/Risk Associate (Pharmacovigilance)
Builds
Signal detection reports and regulatory communications
Domain
Life Sciences / Pharmacovigilance
Deliverable
dashboards & analysis
Required skills
Signal detection, report drafting, quality control, signal evaluation, regulatory communication, record keeping, risk categorization
Preferred skills
Life Sciences or Biomedical education (Pharmacy degree), prior signal detection experience
Technologies
Tracking tools
Responsibilities
Participate in signal detection activities including set-up, review line listings for signal detection reports, draft complex signal detection reports with quality control, evaluate and categorize potential signals, propose courses of action for identified signals, support preparation of communications with regulatory authorities, maintain tracking tools, collaborate with departments on signal management procedures