- Established in the 1990’s, this organisation is an Australian owned pharmaceutical manufacturer who supports the health of Australians by supplying over 60 medicines in critical therapeutic areas.
- Together with manufacturing medicines, they collaborate with hospitals in developing sought after treatment solutions with a focus on hospital specialty pharmaceuticals.
- If environmental sustainability is important to you, this company is committed to protecting and improving the environment. To dramatically reduce its carbon footprint, they are implementing wide ranging and innovative energy efficiency initiatives.
- An equal opportunity employer, this organisation is driven by upholding strong values.
- A company driven by family values and care for its people.
- This Senior Pharmacovigilance and Medical Information Associate role is responsible for all activities relating to Vigilance and Medical Information functions in addition to assisting, where relevant, with Australian and overseas regulatory issues.
- The functions of this role are of a highly skilled and technical nature requiring a depth of experience that would allow the person to be a vital resource for the company in all aspects of the role in order to manage risk as well as other issues that may impinge on the functions in the role, specifically in the areas of product development and overseas marketing.
- Key performance areas for this role include: Vigilance, Medical Information, Regulatory Affairs, Corporate and Governance responsibilities, Risk Management and Medical Advisory.
- You will liaise with the TGA, Medsafe and other authorities as appropriate, including Health Canada, the European Union (EMA), and the United Kingdom (MHRA) authorities to resolve any therapeutic goods pharmacovigilance issues as they occur and fulfil all mandatory reporting responsibilities.
- You will report adverse drug reactions to all relevant authorities in accordance with the methods and timelines set out in company procedures and authority guidelines and regulations.
- You will develop (as required) and maintain a fully functional Pharmacovigilance System which allows the collection and storage of adverse event and adverse drug reaction data for internal reference and TGA submissions.
- You will support the Manager with development and maintenance of SOPs and systems to encompass the timely submission of standardised PSURs to the TGA and/or other international authorities.
- You will draft Periodic Safety Update Reports according to schedule for recently approved products and on request for all other products using template documents and appropriate SOPs and draft and update all submission documentation relating to Risk Management Plans and Vigilance Systems.
- You will regularly review relevant literature databases for international adverse events and issues, providing immediate feedback to the senior leadership team where necessary.
- You will conduct and manage appropriate vigilance strategies for therapeutic goods reviews, adverse events collection, processing and reporting, have appropriate integrated risk management tools in place to protect the company and demonstrate to regulators, prescribers and consumers analytical capability and commitment to drug safety.
- You will respond to Medical Information enquiries from external or internal sources, ensuring compliance with TGA guidelines and industry codes (Medicines Australia Code of Conduct) in all communications and document and file all Medical Information enquiries.
- You will draft and circulate position papers summarising available data relating to medical information enquiries both internal and external and as required, you may provide written scientific/clinical opinions on issues relating to patient safety and medical information requests.
- You will prepare for and participate in internal, business partner and Health Authority audits.
- You will ensure appropriate CAPA plans are implemented and actioned and ensure follow through to close out after inspection/audits.
- As required, you will arrange and conduct training of relevant employees and contracted third parties, on adverse event reporting and maintain up-to-date knowledge of therapeutic areas and products to ensure accurate information can be provided through training.
- You will collaborate with other Medical Affairs, Regulatory, Quality and Commercial teams to ensure PV integration across all functions necessary within the business.
- You will assist with the drafting and development of international leaflets, for example, Reference Safety Information, Product Monograph, Patient Information Leaflet, Summary of Product Characteristics.
- Relevant university degree qualifications.
- Experience in a similar role within the pharmaceutical industry.
- Ideally you will have experience across drug safety, medical information, and regulatory affairs.