Job Title

Aspen Australia is one of the largest pharmaceutical companies in Australia. We have built a portfolio of iconic brands in the prescription and OTC markets, and are the market leader in several categories. We''re a business of 600+ innovative thinkers, inspired to make a difference to individual lives by providing quality, affordable medicines and healthcare products.We are currently seeking an experienced Senior Pharmacovigilance Associate to join our Scientific Affairs team based in St Leonards. This is a key role supporting patient safety and regulatory compliance across Aspen''s prescription and OTC portfolio.Reporting to the Pharmacovigilance Manager, you will support the day-to-day operations of the Pharmacovigilance function in line with TGA, EMA, ACCC and other applicable Health Authority regulations, as well as ICH Guidelines.Key responsibilitiesReceive, track and process adverse event and safety reports, including full data entry and MedDRA coding of ICSRs in the corporate safety databasePerform quality control and review of ICSRs to ensure accuracy, completeness and regulatory complianceNotify business partners of ICSRs and conduct follow-up with consumers, healthcare professionals, distributors and license partners as requiredExpedite case reporting to the TGA within regulatory timelinesReconcile adverse event data with internal departments and external partnersReview scientific literature for safety information related to Aspen productsSupport PSUR and RMP (ASA) review activitiesDevelop, review and maintain Pharmacovigilance SOPs, work instructions and local proceduresDeliver and track pharmacovigilance training for relevant staff and customer-facing teamsSupport audit and inspection readiness and participate in audits as requiredMaintain Good Pharmacovigilance Practice (GVP) and Good Documentation Practice (GDP) standardsIdentify PV system gaps and contribute to continuous improvement initiativesAbout youYou are a detail-oriented and well-organised pharmacovigilance professional with strong communication skills and a proactive mindset. We are looking for someone who will bring:A Bachelor''s degree in Pharmacy, Medical Science, Health Sciences or a related discipline3+ years'' experience in Drug Safety / Pharmacovigilance within the pharmaceutical industrySound knowledge of local pharmacovigilance regulations and global PV guidelinesExperience using a drug safety database (e.g. ARISg, Argus) and exposure to MedDRA codingStrong written and verbal communication skills with the ability to engage confidently with internal and external stakeholdersExcellent attention to detail, organisational capability and time management skillsThis is an excellent opportunity to step into a senior pharmacovigilance role within a well-established pharmaceutical organisation, where you can make a meaningful impact on patient safety and regulatory excellence. #J-18808-Ljbffr