Commercial Eyes’ Medical Services division was only three-strong when Deidre Voss, the team’s current manager, joined the company in 2005. Testament to the growing importance of this area, Medical Services now has 25 staff.
‘Over the last couple of years the demand for a quality outsourced medical information and pharmacovigilance service has grown,’ Deidre says. She put a significant amount of that growth down to a number of factors, including the realisation that outsourcing medical is a sensible option, a greater awareness by smaller companies of a sponsor’s obligations in terms of TGA post-market requirements, and an increase in the number of generic companies registering products in Australia.
‘New companies operating in the Australian market obviously have to abide by TGA requirements and the systems and processes that support these,’ she adds, explaining that these companies often lacked the infrastructure and/or expertise to manage medical functions and TGA requirements in-house. ‘So they see it as a sensible business strategy to work with us in a collaborative partnership arrangement.’
Before Commercial Eyes, Deidre worked in pharmaceutical manufacturing at Faulding’s oral dose plant in Adelaide. She later moved to the company’s Melbourne-based sterile injectable facility
‘My role initially involved manufacturing and packaging operations, then later taking on the role of customer service manager, responsible for domestic and international customer service, warehousing and distribution,’ she says, adding that she also managed production staff training.
Deidre believes one of the key attributes she brings to Commercial Eyes is her experience in quality systems and process.
‘That’s paramount in an injectable manufacturing facility, and translates to any quality driven organisation such as Commercial Eyes, and in particularly our Medical Services provisions. One of my key objectives has been to ensure we achieve ISO9001 certification, which we are expecting very soon.’
Medical Services provides client partners with a wide range of support. It offers a medical information pharmacovigilance service, creating long-term relationships with companies that range in size from top five pharma entities to one-person/ one-product operations.
‘We provide services, tailored to meet our clients’ specific needs. For one client that might be managing medical information, pharmacovigilance and medical affairs activities for an entire product range, or for another client it might be limited to ad hoc, medical information overflow support on a client-dedicated telephone line for doctors, pharmacists, patients, and carers who ring in with medical enquiries.’
The Medical Services team also provides adverse event reporting services for a number of its clients.
‘We act as the Qualified Person for Pharmacovigilance (QPPV) for many clients and handle TGA adverse event-related questions or follow-ups. Our service flexibility also extends to reporting to local, regional and global safety departments.
‘In addition to that, we also provide a full medical affairs service including, development, production and delivery of medical training materials, medical literature reviews and code of conduct reviews on promotional materials,’ Deidre says, explaining that means ensuring companies’ claims about their products are valid. ‘That goes down to even the size of the font in the product brochure a sales rep hands out to doctors.’
Deidre says creating risk management plans and related materials effectiveness testing is another recent addition to her team’s service offerings.
‘The TGA is increasingly requesting that, for some products, the registration dossier includes a Risk Management Plan (RMP), and therefore well thought out risk minimization strategies for post launch.’
The Medical Services team works within agreed timelines and offers total attention to detail. The client, TGA and international reporting timetables must be adhered to. This often means that from the time they hear about, for example, an adverse event, Deidre and her team have until close of business on any given day to make the reporting deadline.
‘The quality of the information we gather and the response we give during a medical information call is very important,’ she says. ‘We have to determine if an enquiry relates to a patient and if so whether an adverse event has occurred. This then requires very specific questioning to determine the details of the event and subsequent action. For medical information enquiries, it is also important that we abide by the MA code of conduct and only answer the question that we are asked based on clinical evidence, predominantly using the approved Product Information or Consumer Information. You can’t go on a tangent; you have to give as much detail as is relevant.’
Obviously, to provide such a wide-ranging service, the Medical Services team’s experience and expertise must be equally diverse.
‘The team is fantastic, very professional,’ Deidre says, explaining that most are either pharmacists or pharmaceutical scientists. ‘They are very experienced with previous roles in large pharma and hospital settings; they’ve got a lot of depth to their knowledge and understanding across prescription and complementary medicines as well as devices. And they bring diversity to our clients, who appreciate that.’
Deidre is effusive about Commercial Eyes, saying she loves coming to work in what she describes as a ‘great environment’.
‘It’s demanding, but it offers flexibility as well,’ she says, adding that she loves the diversity of people she works with, both in her team and externally. ‘I am daily able to interact with and have a really positive relationship with all my clients.’
Deidre says the Medical Services team has unique current and near-future opportunities to serve its clients.
‘There are new TGA pharmacovigilance guidelines in draft at the moment, which aim to bring together listed and registered medicines. There will be a challenge to educate clients in the complementary medicine space on these guidelines and how to best meet them, then implementing systems and processes in their own organisations to support them,’ she says, adding that the RMP’s area will continue to grow.
‘Supporting clients with the drafting, testing and implementation of risk management plans will continue to be an important focus for us, many resulting in special patient or product monitoring programs for which we’ve developed quite an expertise.’