Oviya MedSafe – Perfecting Professionalism in Pharmacovigilance

Dear Well-wishers,

It is my utmost pleasure to connect with you through this January 2023 edition of Oviya MedSafe‘s newsletter (the 122nd in the series since April 2012) which aspires to underline the true essence of professionalism in the context of providing Pharmacovigilance services and takes pride in proclaiming how Oviya MedSafe resolutely stands tall as an embodiment of this virtue.

The Brittanica Dictionary defines Professionalism as the skill, good judgment, and polite behaviour that is expected from a person who is trained to do a job well. Naturally, this also applies to organizations that provide professional services. Oviya MedSafe, as an organization, has emphasized these tenets of professionalism right from Day One. In fact, our August 2019 newsletter ‘Oviya MedSafe – Refining Managed Services in Pharmacovigilance‘ had already focused on Oviya MedSafe’s professional approach in setting up and running Pharmacovigilance projects. Yet, I re-visit this topic today in order to close the loop by talking about adoption of professionalism at the time of close-out of a Pharmacovigilance project.

One might wonder if professionalism is so significant during handover of a project but very few realize that emanating professionalism is much more important at that time rather than at the beginning or in the course of the project. Many a time, our clients have complained that their previous service providers had left them in the lurch after they were notified of the termination of their business engagement, even though such a decision was made well within the terms and conditions mutually agreed in their contract. Unfortunately, such thoughtless actions of small-minded service providers leave clients with a bad aftertaste and as a result, they find it difficult to trust any service provider for that matter. This, I present to you as the 5th in the series of Oviya MedSafe’s Pharmacovigilance Business Pearls: “Professionalism does not refer to the act of merely doing the right things while in the euphoria of having been awarded a contract. True professionalism is demonstrated only when one delivers the committed work with unaltered enthusiasm until handover“.

The first step in achieving professionalism in handover is by making sure that the handover processes for any relevant activity are clearly explained in the Pharmacovigilance service provider’s Standard Operating Procedures (SOPs) and the concerned project-specific documents. While not an exhaustive list, the following points could be considered to constitute a high-level approach towards handover across all Pharmacovigilance activities:

1. Collate processed data across different platforms and systems
2. Send processed data to client (if already sent, need to be reconciled)
3. Original source documents and client-specific written procedures need to be returned to the client or recalled/destroyed by both ends, as agreed
4. Ensure that relationships with all involved third party personnel (such as QPPVs) or organizations (such as PV database providers) are properly terminated and documented
5. Close the open action items especially regulatory queries before the decided date for handover
6. Perform data migration of computerised systems & PV database electronically (wherever applicable)
7. Review and archive/delete customized algorithms prepared for the client project
8. Share high-level trackers of work done (except internal delegation and individual performance assessment logs)
9. Ensure reconciliation of periodic work reports submitted to the client
10. Audit/inspection reports and related documents such as deviations raised, applied CAPAs, File Notes, Change Controls, etc, to be re-reviewed and archived
11. Archive important e-mail communications with regulators or other partners with a traceable legend in the tracker
12. All important trainings and meetings need to be documented and approved by way of Minutes of Meeting and/or Attendance Sheets, as appropriate
13. Review the translated documents with applicable certificates/purchased literature articles or critical safety data from paid sources
14. Agreement to be arrived/finalized with client on support required/offered during future audits of work done by provider during project period
15. Confirm completion of work and surrender all access to client environment/revoke client access to service provider environment
16. Return client-issued laptop computers and/or other hardware devices and make sure the safe receipt is acknowledged by both sides
17. Final sign-off e-mail and reply from client to be archived

Apart from the above, it is understandable that the general clauses in the Master Services Agreement and the applicable Statements of Work should be re-reviewed to make sure that the termination of the contract is in line with the provisions of these agreements and documented accordingly. Confidentiality and Data Protection clauses which may survive the termination of these agreements need to be made clear to both sides, with the duration of the survival unambiguously mentioned in writing.

I am sure you would have understood by now that making the above synopsis has been possible only because Oviya MedSafe follows all the abovesaid procedures in letter and spirit. We hold the unshakeable belief that excellence will be our result only if perfection is our aim. And so, it has always been so and shall remain so forever!

Looking forward to meet you through our February 2023 newsletter,

With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)

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

Director,
Oviya MedSafe UK Ltd,
London, UK
Phone: +44 20 3393 6037

Web: www.oviyamedsafe.com
Mail: info@oviyamedsafe.com
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