Local Contact Person for Pharmacovigilance and Regulatory Affairs (Contractor position)

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.

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

Requirements

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); Proficiency in English; Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint

Nice to have

Experience in case handling, literature screening, or local PV activities; Prior experience in Regulatory Affairs; Additional language knowledge