External Safety Officer or QPPV, Post-Market Surveillance, Cosmetovigilance…
…all these are positions and topics for which our client from the industries of pharma, medical devices, cosmetics or chemicals encounter human resource issues. So, they ask us to help them find self-employed consultants, freelancer, interim manager.
A mid-sized pharmaceutical company has a backlog in their Drug Safety department. A heap of safety cases lies there and they can’t risk to fail the strict deadline provided by the regulations. K-Recruiting then presented 3 medical doctors with many years of experience in SAE Management for the needed TAs. They even could have acted as external QPPV and surely support with writing PSURs. The backlog is taken care of and no authority will complain about missed deadlines!
Medical Devices & Diagnostics
Companies producing or selling medical devices and diagnostic products are regulated by guidelines, such as 93/42/EWG. It makes them responsible to have a surveillance system for post-market surveillance in place. It serves as a system to document, analyse and process data. For example from clinical studies of registered products. Accordingly they will ask us for a freelance Safety Officer for Medical Devices as a temporary solution. Because latest 30 days after a potential risk became know the authority has to be notified and all following measures have to be coordinated without flaws. If there is potential high risk the deadline reduces to right away! With a big enough product portfolio there can be lots to do. Good if you can assign a freelancer who can start support you within days.
In the chemical industry there are two big topics to be considered when it comes to safety. Environmental compatibility, to ensure that no harm comes to nature and the environment from hazardous effects of a chemical substance. Depending on the local and national regulations you have to oblige to, these will be more or less strict or strictly enforced. Moreover, dietary safety is especially important when talking about agrochemicals. Imagine a new pesticide for farming has toxic ingredients.
Similarly, harmlessness to your skin after using your daily beauty products must be ensured. Allergens is the word that surely first comes to mind. But there are other adverse effects that may be triggered by creams or emulsions. Cosmetovigilance is a very important function in any cosmetic company to ensure that any unwanted or unexpected effects after application of a product are reported to the authorities and reach the user.
No matter in which area of the life sciences industry your company operates, be sure, we can give you the right freelance solution to solve bottlenecks and challenges!