Job Title

Accelagen is a leading, locally positioned and globally adept Clinical Research Organisation (CRO) based in Australia, partnering with innovative clients around the world to drive meaningful advancements in human health and wellness. With over a decade of proven success, we bring extensive experience across a diverse range of health, wellness, and disease spectrum. We offer end-to-end services spanning Strategic Consulting, Clinical Trials, Regulatory Affairs, and Biometrics, enabling us to deliver impactful solutions that shape the future of human health wellness.We are looking for a highly organised and diligent Pharmacovigilance Associate (PVA) to join our growing team for 12-month Parental Leave cover. This role is responsible for managing pharmacovigilance on clinical trials and post-marketing adverse events and product complaint reporting in accordance with local and international regulatory requirements.Key Responsibilities:Adverse event & product complaint management - receive, acknowledge, and ensure follow-up on adverse event, serious adverse event, and product complaint reports from clinical sites, HCPs, and consumers.Review & query generation - review reports for completeness, generate queries for additional information, and ensure accurate data collection for individual case safety reports (ICSRs).Case tracking & follow-up - log and track ICSR data in the database, ensuring timely follow-up in line with procedures.Compliance & reporting - ensure compliance with regulations for adverse event, reaction, and product complaint reporting, and generate reconciliation reports within specified timeframes.Regulatory reporting - generate regulatory report listings as required by health authorities.Collaboration & support - collaborate with the pharmacovigilance team and medical monitor to maintain the safety profile of clinical trials and marketed productsPost marketing - acknowledge receipt of all adverse reaction and serious adverse reaction reports sent through from HCPs or consumers as spontaneous reports for marketed productsQualifications:Bachelor''s degree in pharmacy, Bio-Medical Science or Science (Pharmacology) or Post-graduate qualifications in a Science or Allied Health.Additional pharmacovigilance certifications or a master''s degree is a plus.Experience:At least three years of proven experience successfully undertaking a Pharmacovigilance/Pharmacovigilance Associate role within a commercial organisationExperience in the development and delivery of training materialsExperience in implementing a new databaseSkills:Excellent communication and interpersonal skills for liaising with Investigator site staff, CRAs, and external PCHs/consumersExcellent organisational skills and the ability to balance multiple priorities and conflicting deadlines.Working knowledge of Pharmacovigilance regulationsExcellent attention to detailWhat we offer:Competitive salary and benefits package.Opportunities for career growth and professional development.A dynamic and collaborative work environment.Employee wellness initiatives and work-life balance support.Opportunity for flexibility - A part time arrangement with coverage over 5 days per week may be considered.How to Apply:If you are looking to work within a close team, in a flexible, warm and engaging environment and culture, please apply now!#J-18808-Ljbffr