Manager, Local Pharmacovigilance
Core
Manage local pharmacovigilance systems, ensuring compliance with national laws, overseeing ICSR collection, signal detection, and liaison with competent authorities.
Role type
Manager, Local Pharmacovigilance
Builds
Local PV systems, safety communications, and regulatory submissions
Domain
Life Sciences / Regulatory Affairs / Pharmacovigilance
Deliverable
client delivery
Required skills
Local PV system setup and management, ICSR collection and management, literature search, PSMF maintenance, PVA management, PSUR/RMP adaptation and submission, signal detection, risk minimization measures implementation, audit and inspection participation, PV reporting, training coordination, SOP development, liaison with competent authorities, medical information request handling
Preferred skills
Regulatory affairs certification, quality management certification, compliance certification, auditing certification
Technologies
Pharmacovigilance systems, PSMF, PSUR, RMP
Responsibilities
Set up and manage the local pharmacovigilance system, conduct local literature searches, manage local ICSR collection, maintain local PSMF, adapt and submit PSUR/RMP, perform local signal detection, implement risk minimization measures, review materials for post-authorization safety studies, participate in PV audits, provide monthly PV reports, ensure PV training, act as official liaison with competent authorities, notify health authorities of safety concerns, coordinate national safety communications, ensure system updates and validations
Seniority
Manager, hands-on leadership with operational oversight
