Senior Specialist, Local Pharmacovigilance
Core
Manage local pharmacovigilance systems, oversee safety reporting, and ensure compliance with national laws for pharmaceutical products.
Role type
Senior Specialist, Local Pharmacovigilance
Builds
Local PV systems, safety reports, and regulatory submissions
Domain
Life Sciences / Regulatory Affairs / Pharmacovigilance
Deliverable
client delivery
Required skills
Local literature search, ICSR collection and management, PV intelligence screening, PSMF maintenance, PVA management, PSUR/RMP adaptation and submission, signal detection, risk minimization measures implementation, audit and inspection participation, PV training coordination, liaison with Competent Authorities, SOP development
Preferred skills
Regulatory affairs certification, quality management certification, auditing certification
Technologies
Pharmacovigilance systems, Standard Operating Procedures
Responsibilities
Set up and manage local PV system, conduct local literature search, manage local ICSR, perform PV intelligence screening, maintain PSMF, manage PVA, adapt and submit PSUR/RMP, detect local signals, implement risk minimization measures, review post-authorization safety study materials, participate in audits/inspections, provide monthly PV status reports, train affiliate employees and third parties, liaise with global PV system and Competent Authority, issue and maintain local PV procedures, escalate medical information requests, ensure 24/7 availability for safety matters, notify health authorities of significant safety concerns, coordinate national safety communications, update and validate local PV system
Seniority
Senior, hands-on IC
