Local Contact Person for Pharmacovigilance and Regulatory Affairs (Contractor)
Core
Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs ensuring compliance with national requirements in Australia.
Role type
Specialist Local RA & PV Network (Contractor)
Builds
Local pharmacovigilance system and regulatory compliance for the Australian market
Domain
Healthcare / Pharmacovigilance / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory intelligence screening, Adverse Drug Reaction (ADR) collection and reporting, risk minimization management, local QA tasks, documentation preparation, linguistic input on product information
Preferred skills
Communication with regulatory authorities, audit and inspection support
Technologies
None stated
Responsibilities
Communicate with MAH and local regulatory authorities, collect and report locally suspected ADRs, manage risk minimization measures, screen local literature and regulatory websites for safety information, maintain local records, support global RA & PV operations, prepare documentation for regulatory submissions, review local Product Information, support audits and inspections, handle local QA tasks
Seniority
Specialist, hands-on IC
