About this role
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 requiredPrimary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirementsProvision 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 issuesSupport with development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulationsPerform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety informationMaintain accurate records and documentation at local levelProvide support to the RA & PV Global operations teamPreparation and collection of documentation for submissions to the regulatory authoritiesReview and linguistic input on local Product Information and Mock-ups Ensure compliance with MAH's and PrimeVigilance's proceduresSupport audits and InspectionsHandle 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 experienceAt least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environmentGood understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure)Experience in case handling, literature screening, or local PV activities is preferredPrior experience in Regulatory Affairs is preferred but not mandatoryProficiency in English and additional language knowledge is advantageousStrong skills in Microsoft Office applications, including Word, Excel, and PowerPoint When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
Quality: we hold ourselves to the standard patients deserve. Integrity and trust: we do the right thing, especially when it is hard. Drive and passion: we care about the outcome, because someone is waiting on it. Agility and responsiveness: we move quickly, because patients cannot wait. Belonging: everyone is welcome, and every voice counts. Collaborative partnerships: we go further by going together. We look forward to welcoming your application.