Specialist, Local Regulatory and PV network

Job description

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 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. Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We 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. That 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. If 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.