Senior Specialist, Client Facing Scientific Consulting
Core
Manage local pharmacovigilance systems, oversee safety reporting, and act as the official liaison with national health authorities for a pharmaceutical client.
Role type
Senior Specialist, Client Facing Scientific Consulting (Pharmacovigilance)
Builds
Local PV systems, safety reports, and regulatory submissions for pharmaceutical products
Domain
Life Sciences / Pharmacovigilance / Regulatory Affairs
Deliverable
client delivery
Required skills
Pharmacovigilance system setup and management, ICSR collection and management, PV intelligence screening, PSUR/RMP adaptation and submission, signal detection, risk minimization measures implementation, audit and inspection participation, health authority liaison, SOP development and maintenance
Preferred skills
Regulatory affairs certification, quality management certification, compliance auditing certification
Technologies
Pharmacovigilance systems, PSUR/RMP templates, safety communication tools
Responsibilities
Set up and manage the local pharmacovigilance system, conduct local literature searches, manage local ICSR collection, perform PV intelligence screening, maintain local PSMF, adapt and submit PSUR/RMP, conduct local signal detection, implement risk minimization measures, review materials for post-authorization safety studies, participate in PV audits and inspections, provide monthly PV status reports, ensure PV training for affiliates and third parties, 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
