Analista de Farmacovigilância Sr (LatAm)
Core
Senior Pharmacovigilance Analyst ensuring quality management, regulatory compliance, and safety monitoring for Galderma's dermatology products across Latin America.
Role type
Senior Pharmacovigilance Analyst
Builds
Compliance with Latin American, regional, and international pharmacovigilance regulations and global policies.
Domain
Dermatology / Life Sciences / Regulatory Affairs
Required skills
Pharmacovigilance legislation expertise, audit execution, adverse event reporting, periodic safety reporting, risk minimization planning, KPI management, stakeholder engagement with health authorities
Preferred skills
Technovigilance, NOTIVISA, CVS knowledge
Technologies
Electronic regulatory agency reporting forms, audit management tools
Responsibilities
Ensure quality management of PV procedures and audit findings; Respond to Health Authorities regarding safety information 24/7; Operate post-marketing surveillance and submit adverse event reports; Implement and update PV procedures; Conduct training on PV actions; Elaborate periodic PV reports and Risk Minimization Plans; Notify spontaneous adverse event reports to Health Authorities; Manage PV files following Good Practice; Participate in meetings with national entities; Control compliance metrics via KPIs; Support and execute corporate and distributor audits.
Seniority
Senior, hands-on IC