Specialist, Local Regulatory and PV network

The RA & PV specialist will act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) and serves as the primary local RA&PV representative to ensure compliance with national pharmacovigilance and regulatory requirements in Australia. This position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.
Main responsibilities
Prompt and effective communication with MAH and local regulatory authorities as required
Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements
Provision of local regulatory intelligence screening and expert advice for the responsible region(s)
Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
Support with development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations
Perform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety information
Maintain accurate records and documentation at local level
Provide support to the RA & PV Global operations team
Preparation and collection of documentation for submissions to the regulatory authorities
Review and linguistic input on local Product Information and Mock-ups
Ensure compliance with MAH's and PrimeVigilance's procedures
Support audits and Inspections
Handle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market
Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment
Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure)
Experience in case handling, literature screening, or local PV activities is preferred
Prior experience in Regulatory Affairs is preferred but not mandatory
Proficiency in English and additional language knowledge is advantageous
Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint

Employment type
Full-time

Work arrangement
Yes