Local Contact Person for Pharmacovigilance and Regulatory Affairs (Contractor position)
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 and regulatory compliance systems for the Australian market.
Domain
Pharmaceutical industry, Pharmacovigilance, Regulatory Affairs
Required skills
Pharmacovigilance case handling, Literature screening, Regulatory intelligence, Risk minimization management, Documentation management, Quality alert handling
Preferred skills
Regulatory Affairs experience, Additional language knowledge
Technologies
Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Communicate with local regulatory authorities, Collect and report suspected ADRs/ICSRs, Manage risk minimization measures, Screen local literature and regulatory websites, Prepare documentation for submissions, Support audits and inspections, Handle local QA tasks
Seniority
Mid-level Specialist
