Dear Well-wishers,

Brimming with the enthusiasm I derive by connecting with all of you, I pen this June 2021 edition of Oviya MedSafe‘s newsletter (the 105th in the series since April 2012)! In this edition, I wish to speak about one of our niche areas of expertise which evolved from the comprehensive approach Oviya MedSafe adopted towards Pharmacovigilance right from the beginning, and has turned out to be extremely successful in strategically solving complicated pharmacovigilance problems faced by some of our clients that are leading multinational pharmaceutical companies.

Let me start by recollecting the occasion which made me realize that this topic would be worth elucidating, namely the annual conference ‘International Pharmacovigilance (PhV) Days‘ organised by LS Academy, Italy from 14th to 18th June 2021. I was invited to represent India in the roundtable session “GVP-like legislation outside Europe: overlap and differences” in this virtual event during which I enjoyed the insightful interactions with the moderator Martijn van de Leur and my co-panelists Dr Lidia Maksyutkina (Russia/CIS), Mina Awad (Middle East Asia) and John Barber (UK). The roundtable session clearly brought out the unique features of pharmacovigilance activities required to be carried out at local/regional affiliate levels and the challenges involved in aligning the strategies of individual units with the corporate pharmacovigilance policies of the organization. Apart from such country-specific or region-specific pharmacovigilance requirements, it is understandable that any kind of business transformation that a pharmaceutical company undergoes too would warrant mature pharmacovigilance expertise for ensuring smooth transition. Such instances could include stages like mergers/acquisitions, management restructuring, inspections at the affiliate level, change of focus products/markets, new pharmacovigilance partners, etc.

In any of the above-mentioned scenarios, relevantly qualified and reasonably experienced pharmacovigilance professionals would be required in order to thoroughly analyze the way forward and then drive appropriate action on behalf of the pharmaceutical company, especially for a defined short to intermediate period of time. Even though pharmaceutical companies can have this role in-house, they prefer to outsource it considering the contract nature of the role and its comparatively shorter period of engagement. Further, having this role itself outsourced to a third party gives the client the ability to empower this candidate to dispose their duties with full authority as if they were a totally independent person which would practically seldom be the case if the client directly employed this candidate. Now, for the most important point: What matters is not just the length of the experience the target candidates have in pharmacovigilance but also the types of activities they are proficient in handling. It is here that people who have worked purely in operational roles in pharmacovigilance may not be of help. Instead, prior experience in handling strategic pharmacovigilance activities, particularly the ability to liaise with their large scale global service providers in pharmacovigilance would be invaluably helpful. We at Oviya MedSafe have always ensured that our cross-sectional grasp of pharmacovigilance has cascaded right to the newest member of our team and stand out as a natural choice for such projects.

Oviya MedSafe has always been a proponent of practising participative management at the workplace and with our prowess in providing such carefully selected pharmacovigilance experts as specialist consultants for our clients; we firmly believe that we have everything in place to support such client requirements. We already have quite a few multinational pharmaceutical clients in this specialised consultancy model and aspire to develop this into a separate vertical, considering the fact that there are many experienced pharmacovigilance professionals in India who wish to take up such challenging assignments.

Leaving you with this thought, I would like to conclude this month’s note, of course not before sharing with you the recording of the 90-minute webinar ‘Medico Legal Implications of Adverse Drug Reactions‘ I moderated in my honorary capacity as the Chairman of the Indian Medical Association (IMA) Headquarters Standing Committee for Pharmacovigilance, featuring Dr Subhrojyoti Bhowmick and Ms Binota Roy (Advocate) as the expert speakers. Please click on to watch the recorded webinar. Kindly feel free to share your feedback with me in reply and do participate in our future initiatives.

Waiting to meet you through our July 2021 newsletter shortly,

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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