24th March, 2025
About DBG Health:
DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 1,000 dedicated professionals, we are committed to delivering affordable and innovative solutions that enhance the well-being of our customers. Our organization is built on a foundation of strong values, fostering a culture where our people go above and beyond for each other and our clients. At DBG Health, we aim to foster a values-led culture and a place where people go above and beyond for each other and our customers. We strive to inspire and build the capability of our people so they can grow and be the best they can be, and build a high performing team focused on achieving our Vision, Mission and Strategic Objectives. Our diverse portfolio includes Arrotex Pharmaceuticals, VidaCorp Consumer Goods, Independent Pharmacies of Australia Group, and Axe Health Services.
About the role:
The PV Manager will serve as the primary Pharmacovigilance contact responsible for Pharmacovigilance for the local regulatory authority. This role involves overseeing pharmacovigilance system implementation, risk management activities, and maintaining product benefit-risk profiles. The PV Manager will also act as the key liaison with external vendors, regulatory bodies, and marketing authorization holders to ensure compliance and product safety.
Role & Responsibilities:
- Maintain an overview of medicinal product safety profiles and emerging safety concerns.
- Ensure quality, correctness, and completeness of pharmacovigilance data.
- Act as the primary pharmacovigilance contact for competent authorities and business partners.
- Respond to safety-related requests from competent authorities and provide relevant benefit-risk information.
- Stay up to date with regulatory requirements/SOPs and ensure compliance with local legislation.
- Oversee third-party vendors and marketing authorization holders for PV training and compliance.
- Manage the performance of Arrotex PV services providers, ensuring KPIs are met
- Develop and oversee PV systems in compliance with required standards.
- Ensure accurate management of PV data in electronic repositories, including adherence to disaster recovery plans.
- Oversee the collection and processing of Adverse Events/Adverse Drug Reactions in line with local regulations.
- Monitor and review significant safety issues and other safety trends in collaboration with internal and external stakeholders.
- Support the development of Periodic Safety Update Reports and collaborate with Regulatory Affairs.
- Conduct signal detection activities for all medicinal products and monitor global safety data reports.
- Promote compliance and continuous improvement by implementing relevant SOPs and Work Instructions.
- Ensure training and awareness of pharmacovigilance obligations across internal teams and external partners.
Skills & Experience: - Knowledge and understanding of local and global pharmacovigilance guidelines.
- Strong collaboration, interpersonal and communication skills including the ability work in cross-functional teams.
- Strategic thinking and high integrity, including strong ethical and scientific standards.
- The ability to work precisely according to procedures, rules, and regulations.
- The ability to manage and resolve issues effectively.
- Flexibility and ability to work in a fast-paced, rapidly changing environment on multiple projects with tight deadlines.
- 7 + years in the pharmaceutical industry with knowledge in pharmacovigilance.
- Minimum 5 years of relevant experience in Pharmacovigilance.
- Held previous pharmacovigilance manager role in the pharmaceutical industry
- A tertiary qualification, ideally in pharmacy or life sciences
- A post-graduate qualification in a related area would also be an advantage.
- Full Australian Driver’s licence
Benefits & perks: At DBG Health, we offer more than just a job – we offer a dynamic and supportive work environment where you can make a real impact. As part of our team, you'll have the opportunity to work alongside industry leaders, drive meaningful change, and grow both personally and professionally.
- Exclusive discounts on our consumer health, wellness and beauty products - including MCo Beauty, E.L.F Cosmetics, Nude by Nature. Chemists Own and many more
- Free membership to 28 by Sam Wood - 28 by Sam Wood is an online program designed to help Aussies get fit at home and live happier, healthier lives. From guided workouts and expert-created meal plans to motivational resources, it’s designed for people of all fitness levels.
- 12 weeks paid parental leave
- Access discounted private health insurance through Australian Unity, AIA Health of NIB
- We are a values-driven business fostering a supportive and friendly team culture
- Enjoy the ability to work autonomously, empowering you to drive your own success.
- Convenient head office location close to public transport, cafes and restaurants
- Opportunity to grow your career across all divisions within DBG Health - Arrotex Pharmaceuticals, VidaCorp Consumer Goods, Independent Pharmacies of Australia Group and Axe Health Services.
- Ability to purchase additional leave to provide opportunity for employees to spend more precious time with family, travelling or even study
- Explore the option of paying for your vehicle costs through novated leasing
DBG Health is committed to fostering a workplace culture that is safe and accessible for all. We are an equal- opportunity employer and encourage applications regardless of cultural background, gender identity, sexual orientation, disability or neurodiversity. We strive to build a collaborative, inclusive workplace that is representative of the communities we work and live in.
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