Regulatory Associate - Pharmacovigilance and Drug Safety
We are Reckitt
Research & Development
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
As a Pharmacovigilance (PV) Associate you will be responsible for the PV and drug safety processes in the local market, ensuring compliance with local legislative requirements for reporting and monitoring vigilance. In addition, you will be responsible for ensuring; Drug safety and vigilance processes are followed and are compliant with both the Global Standards and at a local level. You will act as a catalyst for change, using your detailed knowledge to create comprehensive dossiers crucial for product registrations. At Reckitt, every individual's contribution is key, and your role will be pivotal in navigating the intricate regulatory landscape to deliver products that enrich lives every day.
Your responsibilities
- Execute Drug Safety obligations for Australia and New Zealand per global/local vigilance requirements.
- Advise cross-functional teams on Vigilance matters.
- Manage local vigilance systems and oversee PV activities, including DSO inboxes and documentation.
- Report local Adverse Events (AEs) promptly with anonymized data and follow-up.
- Ensure compliance with local and global Pharmacovigilance, Medical Device Vigilance, and Cosmetovigilance guidelines.
The experience we're looking for
- Degree in in pharmacy, medicine or medical sciences field with a robust understanding of global regulatory environments impacting consumer products.
- A minimum of 1 year in Pharmacovigilance/Drug Safety background OR an applied knowledge from a Pharmacy degree or similar.
- Experience in dossier creation, submission, and product lifecycle management.
- A track record of reviewing and authoring high-quality documents.
- Comprehensive understanding of health AU & NZ regulations
- Great time management skills and ability to managing multiple competing priorities
- Commercially aware, adept at building partnerships and proposing improvements to enhance business processes.
- Capable of embracing change and setting clear objectives in line with our business goals.
The skills for success
Commercial Awareness, Business Partnership, Collaboration, Partnership building, Regulatory, Dossier writing, Collaborator, Product Lifecycle Management, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Objective Setting, Business Strategy.
What we offer
With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
Equality
We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
Job Segment:
Medical Device, Pharmacovigilance, Pharmacy, Counseling, Nutrition, Healthcare