Dear Well-wishers,

As we bid adieu to 2020 and begin 2021 with great hope, I am overjoyed to express my heartfelt wishes to all of you and your families for a very Happy & Prosperous New Year 2021, through this December 2020 edition of Oviya MedSafe‘s newsletter (the 99th in the series since April 2012)! This issue aims to particularly focus on Oviya MedSafe’s flexibilities in addressing our clients’ requirements when they approach us exclusively seeking Pharmacovigilance personnel for working on their projects and further aspires to elucidate why choosing Oviya MedSafe’s Project Outsourcing model rather than insisting on the traditional Contract Staffing model shall work better for any such client of ours.

Every department in any organization needs to carry out different types of routine business operations relevant to its industry. While some organizations choose to perform all such tasks themselves by hiring the right people, some others outsource specific activities in full or part to an external agency to the most practicable extent. In the latter case, the external agency is said to be a provider of Project Outsourcing services. However, when an external agency is asked to merely supply competent people who can work as temporary contractors for a defined period of time, the external agency becomes a provider of Contract Staffing services. Pharmacovigilance, as a department in a pharmaceutical company, is no exception to any of these practices. Accordingly, pharmaceutical companies fulfil their regulatory obligations in Pharmacovigilance either by establishing an in-house Pharmacovigilance team or by outsourcing their work as projects to Pharmacovigilance service providers. In addition, Contract Staffing in Pharmacovigilance is in vogue too. A key point to be noted here is that, although Contract Staffing services are rendered by recruitment firms also, clients prefer signing up with service providers having thorough domain expertise when it comes to niche fields like Pharmacovigilance. Oviya MedSafe too receives and services such requests.

In a Contract Staffing model, Oviya MedSafe would depute to the client’s project the requested number of designated individuals having relevant educational qualification and training along with adequate experience. As these named individuals would become part of the client’s team itself, everything from that point of time would be the client’s responsibility. No peer Quality Control (QC) support, Quality Assurance (QA) review or Senior Management oversight by Oviya MedSafe would be possible. Further, day-to-day line management of these contract personnel will be an additional burden on the shoulders of the client, with scope for Oviya MedSafe’s involvement being restricted to scenarios in which a given individual has to be replaced for any reason. Most importantly, the knowledge base, effectiveness, ability of managing complex tasks, possibility of prioritizing urgent ad-hoc work and overall productivity of the role itself will be limited to a particular individual’s diligence. Due to this dependence, any planned or unplanned replacement of staff will be accompanied by the client’s apprehensions of consistency in terms of productivity, standards, ways of documentation, work prioritization, and so on. Last but not the least: This model will be more expensive as the staff are dedicated to a single client and no ‘shared services‘ benefit exists.

On the contrary, the same work done by Oviya MedSafe in a Project Outsourcing model would be spearheaded by a Project Lead, with a back-up person involved right from the beginning, and both of them reporting internally to their Line Manager within Oviya MedSafe. Additional support in the form of peer QC, QA review & appropriate Senior Management supervision will be extended, as it is Oviya MedSafe’s responsibility to ensure that the deliveries are timely, of high quality, and are in compliance with the not only with the applicable regulatory rules but also with the internal written procedures of Oviya MedSafe and/or the client (as agreed in prior with the client). Thereby, the client is relieved of the pressure of directly managing the project personnel and on top of it has the assurance of an additional strong layer of protection as the entire Oviya MedSafe hierarchy will duly oversee the project throughout its lifecycle. In contrast to the other model, the client will gain a lot from the mature wisdom of Oviya MedSafe as an organization which includes our comprehensive integrated expertise, established ways of working, structured escalation mechanism, and so on. In the Project Outsourcing model, the system is evidently insulated from the occasional fallacies of any particular individual and vouches for better consistency across all parameters. Over and above all these advantages, this model would eventually be more cost-effective for the client as the ‘shared services’ benefit can be passed on to the client.

To summarize: Oviya MedSafe fully understands the pros and cons of Contract Staffing as well as Project Outsourcing. While we are fine to be engaged by our clients in either model, I personally feel that the Contract Staffing model gives the client exactly what they WANT but the Project Outsourcing model helps the client better by giving them what they NEED. And, while a client may derive satisfaction from getting exactly what they want (assuming that they know what they want), getting what they need that too in a highly efficient lean manner could be the biggest comfort they could enjoy. As an organization, we desire that the Project Outsourcing model gets better acceptance in future so that we indeed maximize our clients’ comfort in Pharmacovigilance.

On the personal front, December 2020 was an exciting month. I was privileged to introduce Dr Gerald J Dal Pan, Director – CDER Office of Surveillance & Epidemiology, US FDA to the audience just ahead of his special address at the 7th Annual Pharmacovigilance Symposium of the Indian Society for Clinical Research (ISCR) and also had the honour of moderating a panel discussion “Connecting the Dots in the ADR Reporting Value Chain” featuring Dr J A Jayalal (National President of the Indian Medical Association for 2021) as an expert panellist in the same event which was conducted virtually. Further, it was my pleasure to engage with Mr Deepak Paliwal, Mr Sumit Arora and Ms Indu Nambiar as the other panellists. I wish to once again thank ISCR for this chance.

Outside profession and business too, December 2020 was special for a different reason. For the first time, I literally sang my heart out while wishing one and all for Christmas and for the New Year. It was a heartening feeling to rediscover my singing hobby and use it for wishing my near and dear. While the Christmas song was a famous Tamil film number pertinent to the festival, the one I chose as the New Year song was more from a metaphorical sense reflecting the current scenario of our transition from the challenging 2020 into a promising 2021 during the pandemic. Please click here for my English translation of the Tamil song’s lyrics. Feedback is welcome, as has always been the case!

Keen to meet you soon through our January 2021 newsletter,

With thanks & regards,
Dr J Vijay Venkatraman

Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Coimbatore, India
Phone: +91-422-2444442

Oviya MedSafe UK Ltd,
London, UK
Phone: +44-8452-733839

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