I wish to start this May 2022 edition of Oviya MedSafe‘s newsletter (the 116th in the series since April 2012) by expressing our heartfelt gratitude to all of you who reached out to us at various points of time during the past few months to congratulate us on the 10th anniversary of Oviya MedSafe’s founding and to wish us all the best as we begin our second decade of dedication to the cause of Pharmacovigilance.
From working hard to setting up a global Pharmacovigilance system for ourselves amidst several challenges in the early stages to having evolved into a renowned boutique consultancy firm that specializes in establishing customized global Pharmacovigilance systems for our clients in many different parts of the world, Oviya MedSafe has come a long way. While the entire Pharmacovigilance universe knows about how we have developed genuinely and organically over the years, enduring innumerable hurdles and disappointments, I was wondering if we would have learnt so much had we not grown through all the hardships we had encountered. As a responsible ambassador for Pharmacovigilance, I believe it is justified only if we at Oviya MedSafe shared our experiential wisdom with our colleagues in the Pharmacovigilance fraternity, especially with respect to business relationships and industry practices.
As I sat thinking what term I could use to denote this kind of experience-based knowledge-sharing, a word that I had heard in my medical school struck me: “Clinical Pearls“. According to a published article, clinical pearls are best defined as small bits of free standing, clinically relevant information based on experience or observation. They are part of the vast domain of experience-based medicine, and can be helpful in dealing with clinical problems for which controlled data do not exist. I was surprised that if I replaced ‘Clinical’ with ‘Pharmacovigilance Business’, I had a term for what I wanted to say all along: “Pharmacovigilance Business Pearls”! So, from this edition, I shall present such pearls which I believe would serve as food for our thoughts.
Let us begin this series with the example of a pharmaceutical company with limited in-house Pharmacovigilance expertise that wants their service provider to run their end-to-end Pharmacovigilance operations. While it is tempting for the client to offload all of their Pharmacovigilance activities, one must remember that the tasks may be delegated but the responsibilities of compliance remain with the client. Taking accountability for Pharmacovigilance is unavoidable for any pharmaceutical company irrespective of its level of Pharmacovigilance expertise. So, it is very important for clients to have at least a small team in place to regularly interact with the service provider and have their respective roles and responsibilities documented with timelines. As a service provider, it is an act of prudence rather than that of appeasement to provide sufficient training on basic Pharmacovigilance concepts and the specific details of their business relationship to this small team regardless of how Pharmacovigilance-naive the client may be at an organizational level.
Sometimes, service providers are hesitant to teach Pharmacovigilance to their clients fearing that they would lose future business if the client set up their own Pharmacovigilance unit by learning from them. What is to be remembered is that the current business relationship itself could go in for a toss if the client does not know of what is going on at the service provider’s end. Also, the sense of freedom enjoyed by a service provider when they are not asked any questions by the client is false and temporary at its best. Regulatory inspections or third party audits, whenever they happen, bear the potential to expose this fair-weather friendship between the client and the service provider, leading to unpleasant blame games. The end result could be more traumatizing for the client as they may have to face regulatory action. The service provider too could be taken to task for inadequate service standards depending on the strength of the clauses in their contract. Therefore, proper documentation is critical for service providers even if they have done their part well whereas for clients, sustained oversight of the service provider’s performance is the only way to assure themselves of their own safety.
With the hope that you found this first pearl to be worth pondering upon, I wanted to share with you a brief video felicitation message sent by our good friend from Spain Mr Jose Alberto Ayala Ortiz, a distinguished Pharmacovigilance professional, trainer and auditor, on account of the 10th anniversary of Oviya MedSafe’s founding. I take this opportunity to earnestly thank Jose for tracing our long journey together in Pharmacovigilance over the past decade.
Before concluding, I think of sharing with you a video of my speech at the Indian Pharmaceutical Congress 2015, amidst a stellar gathering of government stakeholders of Indian Pharmacovigilance. That was a time when the Pharmacovigilance Guidance Document for Marketing Authorisation Holders of Pharmaceutical Products was not even conceived. Today, I felt nice to watch it after so many of my suggestions got to be implemented by the authorities in later days.
What was just a moment then exhibits itself as a significant historical timestamp now! I hope you will find this video interesting when you have 15 minutes to spare to watch it, although I regret the low volume of the recorded audio which was so in the source
Keen to meet you with the next pearl in our June 2022 newsletter,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,
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