Senior Specialist, Local Pharmacovigilance
Core
Set up and manage the local pharmacovigilance system, ensuring compliance with national laws and acting as the official liaison with the Competent Authority.
Role type
Senior Specialist, Local Pharmacovigilance
Builds
Local PV system, safety communications, and regulatory submissions
Domain
Life Sciences / Regulatory Affairs / Pharmacovigilance
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, SOP development, liaison with Competent Authority, 24/7 availability
Preferred skills
Certification in regulatory affairs, quality management, compliance, or auditing
Technologies
Pharmacovigilance systems, PSMF, PSUR, RMP
Responsibilities
Set up and manage the local PV system; Conduct local literature search and ICSR collection; Perform PV intelligence screening and signal detection; Maintain PSMF and manage PVA; Adapt and submit PSUR/RMP; Implement risk minimization measures; Review materials for post-authorization safety studies; Participate in audits and inspections; Provide monthly PV reports; Ensure training of affiliates and third parties; Cooperate with global PV systems; Issue and maintain local SOPs; Act as official liaison with the Competent Authority; Notify health authorities of significant safety concerns; Coordinate national safety communications; Ensure system updates and validations.
Seniority
Senior, hands-on IC