Local Contact Person for Pharmacovigilance and Regulatory Affairs
Core
Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs ensuring compliance with national requirements in Australia.
Role type
Local PV & RA Specialist (LCPPV/LCPRA)
Builds
Local pharmacovigilance system and regulatory submissions for the Australian market
Domain
Pharmaceutical industry, Pharmacovigilance, Regulatory Affairs
Deliverable
client delivery
Required skills
Case handling, Literature screening, Regulatory intelligence, Risk minimization management, Documentation maintenance, Audit/inspection support, 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 ADRs/ICSRs, Manage risk minimization measures, Screen local literature and regulatory websites, Prepare documentation for submissions, Review local Product Information, Support audits and inspections, Handle local QA tasks
Seniority
Mid-level specialist
