Oviya MedSafe – Certified MedDRA Coders and Pharmacovigilance Torchbearers
By admin Dear Well-wishers,
I begin writing this May 2017 edition of Oviya MedSafe’s newsletter with tremendous joy on the achievement of an organizational milestone:
Ten of our team members have made Oviya MedSafe proud by clearing the Certified MedDRA Coder (CMC) examination, with all of them taking the test simultaneously and for the first time!
While I express my personal note of hearty congratulations to my ever-reliable colleagues, I wish to add a little more context on the significance of this certification. The CMC examination is a rigorous test of an examinee’s coding ability and knowledge on the Medical Dictionary for Regulatory Activities (MedDRA), conducted by the MedDRA Maintenance and Support Services Organization (MSSO) contractor. The examinees need to have a working knowledge of the principles of MedDRA term selection as outlined in the MedDRA Term Selection: Points to Consider (PTC) document, including preferred options, the details of which may be downloaded from the MedDRA Support Documentation page. The current examination uses MedDRA Version 20.0 and the Term Selection PTC, Release 4.13. The ICH MedDRA Management Board recognizes the importance of continuous MedDRA training as a best practice and the value of a coding certification. However, it is not within its scope to offer such a certification and it is not a regulatory requirement.
As an organization that treats passion for pharmacovigilance, continuous learning to empower clients, perpetual capability-building, and deep-rooted business integrity as its core values (Philosophy) in letter and spirit, Oviya MedSafe sees this certification of our employees as an authentic endorsement of our expertise in the domain. We believe it also validates the high performance of our training and quality management systems, into which we now look forward to bring in further advancement by getting the rest of our (present and future) staff to clear the CMC examination in the forthcoming months.
While on this topic, I believe it would be relevant to share with you that Oviya MedSafe is keen to expand its Medical Review team at Coimbatore, India. The detailed job advertisement is available on my LinkedIn Article and I take this opportunity to invite eligible and interested candidates to apply by sending their CVs to the e-mail address provided.
Oviya MedSafe has always strived to be in the first line of action in any pharmacovigilance activity that it could participate at any level, which has quite appropriately earned for us the descriptor ‘Torchbearers for Pharmacovigilance’ from doyens in the domain, which remark is something I consider quite close to my heart. I firmly believe that it has been due to not my efforts alone but a lot to the camaraderie of my enthusiastic team, to whom I once again wish to express my heartfelt thanks at this moment.
Before concluding this letter, I am happy to inform you that the registrations for the Indian Pharmacovigilance Day 2017 conference which I am to Chair at Hyderabad on 28-July-2017 are now open. Please visit the registration page for more details and to avail the Early Bird benefits which would be available until 30-June-2017. The details of confirmed speakers are already available on the speakers page. The agenda with a few more speakers whose confirmation is awaited, shall be posted on the agenda page soon.
I eagerly wait to share my UK Pharmacovigilance Day 2017 experiences with you through our June 2017 newsletter which you can expect in the first week of next month.
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: +44-8452-733839
Web: www.oviyamedsafe.com
Mail: info@oviyamedsafe.com
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