I am delighted to present this August 2019 edition of Oviya MedSafe‘s newsletter, with the satisfaction of having cleared my backlog of the due monthly missives. In this issue, I wish to highlight a conscious approach by which Oviya MedSafe, on behalf of our clients, has been ensuring the timely performance of their critical pharmacovigilance compliance activities (of comparatively lower volumes per client for numerous clients) in a cost-effective yet quality-uncompromised manner while maintaining sufficient professional supervision which is something each of our clients found to be a unique feature of Oviya MedSafe.
Right from our inception in 2012, Oviya MedSafe has not only taken up routinely outsourced pharmacovigilance assignments but has also strived to fulfil the gap in the industry, namely the provision of customized comprehensive support for a specific range of pharmacovigilance requirements limited by regional regulatory norms, narrow product portfolios or company-defined business needs. This has been possible because Oviya MedSafe was conceived not just as yet another pharmacovigilance service-provider but as a specialized organization that renders consulting as well as outsourced support in global and local pharmacovigilance, with a particular focus on small and medium-sized pharmaceutical companies.
Oviya MedSafe was early to recognize that the majority of the pharmaceutical clients (especially in India and other emerging markets) did not need segmented large teams trained in only one area of pharmacovigilance but rather would benefit from small teams of “pharmacovigilantes” who had a holistic understanding of pharmacovigilance. Hence, our training modules were designed accordingly and we have been successful in building several of such “pharmacovigilantes” over the past 7 years. Naturally, this meant that our team members were always able to be one step ahead of our counterparts in other organizations, thanks to our concentration on “horizontal” rather than “vertical” excellence. With time, this has resulted in the development of Oviya MedSafe’s time-tested business model of administering Managed Services in pharmacovigilance.
By this model, Oviya MedSafe engages with a typical client at the stage of planning the pharmacovigilance activities they are required to perform and works out a clear matrix in which the exact roles of Oviya MedSafe in the engagement are described. In scenarios where a consultative element is involved or an end-to-end outsourcing activity is involved, appropriate project management plans are made and finalized beforehand with the client. However, if the requirement is for an extended team of the client’s that would work with them in a like-minded manner with an excellent understanding of their product portfolio and applicable pharmacovigilance compliance obligations, Oviya MedSafe’s “pharmacovigilantes” would be readily assigned under this Managed Services formula with just enough paperwork to serve as driving documents for the project in question. Led and guided by a Drug Safety Manager, such a vibrant team of “pharmacovigilantes” would have experienced pharmacovigilance professionals deputed in Full Time Equivalent (FTE)-based contracts for that particular client/project. Such FTEs could be either exclusive to the client or shared with other clients based on the volume of work but, in any case, they would be fully governed by Oviya MedSafe’s written procedures and organizational policies. Moreover, Oviya MedSafe’s Medical Safety department will provide its insights wherever required and the whole set of activities will have adequate surveillance by Oviya MedSafe’s Quality Assurance department. While other organizations may also provide such support in a Staff Augmentation model where the onus of getting the work done from the team rests with the client, Oviya MedSafe goes one step further by taking ownership of the productivity and quality of the team’s deliverables by putting thorough internal checks and balances in place. For more information on our Managed Services in pharmacovigilance, please contact us.
Before signing off, let me take the pleasure of sharing with you an interesting article that I had the privilege of editing for the August 2019 edition of DIA’s Global Forum, for which I serve as the India Regional Editor. The regional report for the month was written by Dr Srikanth Krishnamurthy; a leading Pulmonologist & Clinical Trial Investigator based in the city of Coimbatore in India and is titled “Transition from Physician to Clinical Trial Investigator in India: Today’s Research is Tomorrow’s Practice“. True to its title, this report traces the journey of a typical clinician in India through the discipline of Clinical Research. This widely acclaimed article evolved into a niche professional milestone of mine about which I would like to speak in detail, along with a few more interesting updates, in the September 2019 edition of Oviya MedSafe’s newsletter that is to be released shortly.
Thanking you for your continuous patronage and eager to re-connect soon,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,