Pharmacovigilance Senior Specialist
Core
Execute, coordinate, and monitor pharmacovigilance activities for North LATAM Cluster countries, serving as a functional liaison between internal teams, vendors, and business partners to ensure compliance with regulatory requirements and quality standards.
Role type
Senior IC pharmacovigilance specialist (North LATAM Cluster)
Builds
Local pharmacovigilance processes, procedures, systems, and documentation for North LATAM Cluster countries
Domain
Pharmaceutical industry, Latin America regulatory domain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance operations, regulatory reporting, quality system management, audit coordination, risk management, regulatory intelligence, vendor governance, training delivery, business continuity planning
Preferred skills
Regional or global team collaboration experience
Technologies
ICSRs, PSURs/PBRERs, RMPs, CAPAs, Safety Data Exchange Agreements (SDEAs)
Responsibilities
Oversee receipt, processing, follow-up, reconciliation, and reporting of adverse events and safety information; coordinate follow-up of deviations, observations, CAPAs, change controls, and exceptions; monitor pharmacovigilance regulatory changes and contribute to impact assessments; act as a pharmacovigilance contact for internal functions and assess initiatives generating safety information; coordinate and deliver pharmacovigilance training for employees and vendors
Seniority
Senior, hands-on IC
