I am pleased to meet you all through this October 2022 edition of Oviya MedSafe‘s newsletter (the 119th in the series since April 2012) in which I intend to present the next “Pharmacovigilance Business Pearl” from Oviya MedSafe, following up on the topic I first started a few months ago.
Qualified Person for Pharmacovigilance (QPPV) is one term that everyone working in Pharmacovigilance treats with reverence. For the uninitiated, a QPPV is an individual who is personally responsible for the safety of the human pharmaceutical products marketed by a company he/she is associated with, almost always mandated to reside in the concerned country/region and be the single point of contact for the respective regulatory authority on a 24-hour basis. While QPPV as a concept originated in Europe, most countries across the world that are serious about Pharmacovigilance have adopted it into their regulatory systems – many in letter, some in spirit, and a few in both. Hence, knowledgeable QPPVs are needed in multiple regions nowadays.
Oviya MedSafe has been providing QPPV services and Local Responsible Person (LRP) services for EU compliance right from 2013, with UK QPPV also becoming a separate service ever since Brexit became a reality. As we have been utilizing our own EU and UK QPPVs for our clients who awarded end-to-end Pharmacovigilance outsourcing contracts to Oviya MedSafe, we have been able to deliver an integrated QPPV coverage to these clients. Thanks to such rich experience, we came to understand that the customized support of a focused and nimble team was quite helpful for EU and UK QPPVs to carry out their responsibilities diligently. This is true both for a EU/UK QPPV who is an employee of the pharma company he/she represents and for a contract QPPV who supports more than one pharma company, in different ways though, as they have different challenges to overcome. Thus, “QPPV office support” emerged as one of our standalone offerings through which we began assisting external QPPVs from both these categories. Today, Oviya MedSafe’s seasoned and centralized Pharmacovigilance team is well-positioned to help EU and UK QPPVs with bespoke support services as desired by each one of them. This includes Drug Safety Physician services to QPPVs who are not physicians by qualification, as required by regulation.
Having said so much about our QPPV office support for well-regulated countries where our activities are more operational in nature with the goal of helping the QPPV implement his/her plans, I wish to talk about our strategic consultative approach for the developing regions/countries which have enacted laws demanding QPPVs in their jurisdiction but also suffer from a deficit of Pharmacovigilance expertise due to the recency of the legislations. In contrast with the EU and the UK that are home to innumerable QPPV candidates with decades of vast experience in the field, it is somewhat difficult to even identify personnel with relevant educational qualification to fill QPPV vacancies in some of these emerging markets. Pharma companies try to mitigate this problem by partnering with Pharmacovigilance service providers. But, what must be remembered is that outsourcing local Pharmacovigilance activities is much more complicated than outsourcing core global Pharmacovigilance tasks. Oviya MedSafe rises to the occasion by working with the client to proactively identify the right QPPV candidates in those geographies, interview & clear them for hiring by client, train them on Pharmacovigilance, monitor their performance, oversee the compliance metrics, manage their succession plans, etc, due to which the new QPPVs gather confidence over a period of time.
To cut a long story short, QPPV office support is an altogether different package for emerging markets versus what it is for developed countries/regions. Oviya MedSafe is well-versed to handle both these extremes and all the possible variants in between, in a straight-forward and cost-effective manner. Do reach out to us if you have any business needs in this regard.
Before concluding, let me share with you a piece of good news: Oviya MedSafe has literally found a place in history! In a review article titled “History of Pharmacovigilance in India (1983-2022)” written by Dr Syed Ziaur Rahman (with Galib R) and published in the January-June 2022 edition of the Journal of Pharmacovigilance and Drug Safety (an official publication of the Society of Pharmacovigilance, India), Oviya MedSafe has been named as an organization that has contributed significantly to the growth of Pharmacovigilance in India. Particularly, Oviya MedSafe’s newsletters and their usefulness have been highlighted by the authors, for which I express my sincere thanks to them. Please click here to read the review article (page 12 of the PDF) and kindly share your comments by a reply e-mail.
Looking forward to connecting with you in November 2022,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Phone: +91 422 2444442
Oviya MedSafe UK Ltd,
Phone: +44 20 3393 6037