Local Contact Person for Pharmacovigilance and Regulatory Affairs

pMedicine moves forward here. So will you. /p pAt PrimeVigilance, patient safety is not one part of the job. It is why we exist. /p pWe are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on. /p pThat work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from. /p pIf you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you. /p pThe 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 RAPV 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. /p h3Main responsibilities /h3 ul liPrompt and effective communication with MAH andlocal regulatory authorities as required /li liPrimary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements /li liProvision of local regulatory intelligence screening and expert advice for the responsible region(s) /li liCollection and reporting of locally suspected ADRs or icsrs (FUs, translations) /li liLocal management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues /li liSupport with development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations /li liPerform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety information /liliMaintain accurate records and documentation at local level /li liProvide support to the RA PV Global operations team /li liPreparation and collection of documentation for submissions to the regulatory authorities /li liReview and linguistic input on local Product Information and Mock-ups /li liEnsure compliance with MAH's and PrimeVigilance's procedures /li liSupport audits and Inspections /li liHandle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market /li /ul ul liBachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience /li liAt least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment /li liGood understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure) /li liExperience in case handling, literature screening, or local PV activities is preferred /li liPrior experience in Regulatory Affairs is preferred but not mandatory /li liProficiency in English and additional language knowledge is advantageous /li liStrong skills in Microsoft Office applications, including Word, Excel, and PowerPoint /li /ul pWhen 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. /p pWe 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. /p ul liQuality: we hold ourselves to the standard patients deserve. /li liIntegrity and trust: we do the right thing, especially when it is hard. /li liDrive and passion: we care about the outcome, because someone is waiting on it. /li liAgility and responsiveness: we move quickly, because patients cannot wait. /li liBelonging: everyone is welcome, and every voice counts. /li liCollaborative partnerships: we go further by going together. /li /ul pWe look forward to welcoming your application. /p