Pharmacovigilance Analyst
Core
Maintain oversight of local pharmacovigilance (PV) systems to ensure compliance with national laws and regulations, manage local ICSR, conduct literature searches, and implement risk minimization measures.
Role type
Senior IC Pharmacovigilance Analyst
Builds
Local PV systems and compliance reports for pharmaceutical clients
Domain
Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Local PV system oversight, ICSR management, PV intelligence screening, PSMF maintenance, risk minimization measure implementation, audit/inspection participation, SOP development, PV training delivery
Preferred skills
Spanish business fluency, Regulatory Affairs certification, Quality Management certification
Technologies
PV systems, Standard Operating Procedures (SOPs)
Responsibilities
Maintain oversight of local PV system, conduct local literature search, manage local ICSR, perform PV intelligence screening, maintain local PSMF, set up local organized data collection, manage local PVA, implement risk minimization measures, review post-authorization safety materials, participate in PV audits and inspections, provide monthly PV status reports, train affiliate employees and third parties, issue and maintain local PV procedures
Seniority
Mid-Senior, hands-on IC with project leadership
