Analista de Farmacovigilância Pleno
Core
Process adverse event reports, conduct literature searches, and prepare risk management plans and benefit-risk assessment reports for pharmaceutical products.
Role type
mid-level pharmacovigilance analyst
Builds
safety reports and risk management plans for pharmaceutical products
Domain
pharmaceuticals + regulatory safety
Required skills
pharmacovigilance case processing, literature search, risk management plan (PGR) development, benefit-risk assessment report (RPBR) preparation, clinical study support, regulatory compliance knowledge
Preferred skills
clinical trial experience, bioequivalence study experience
Technologies
pharmacovigilance databases, regulatory reporting systems
Responsibilities
evaluate, process, and submit adverse event reports; translate and send reports to partner companies; conduct scientific literature searches; reconcile pharmacovigilance cases; develop risk management plans; prepare periodic benefit-risk assessment reports; support clinical studies and bioequivalence activities
Seniority
Mid-level, hands-on IC