Local Contact Person for Pharmacovigilance and Regulatory Affairs (Permanent or

The Specialist, Local RA & PV Network 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