MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion
Medical Coder
• Responsible for Coding Adverse Events and Concomitantdiagnosis using the current version of MedDRA as distributed by MSSO and inaccordance to the Client specific SOP's.
• Coding of Medical data in a timely manner.
• Ensure Critical studies with consistent coding andhandling issues.
• Coordination of import or export of data for coding andtransfer of data/coded terms to clients.
• Review listing for coding terms to ensure accuracy andconsistency of coded data.
• Consistent with client guidelines and regular checksfor feedbacks.
• Authenticate accuracy of Terms Processed andmaintaining the safety compliance, also ensuring quality standard.
• Documenting the observations on an internal generatedQuality check sheets (quality control form, defect tracker).
• Providing regular feedback to the team members forcontinuous improvement of the process.
• Maintain and Update daily metrics.
• To make sure all the priority study terms are processedon priority.
• Secondary quality Checks of Serious Spontaneous AdverseEvents / Post Marketing adverse event / Clinical trial and invalid terms.
• Maintain knowledge on updates or changes in medicalcoding dictionary versions.
MUST HAVE MEDDRA EXPERIENCE
MakroCare | A MakroGroup Company | www.MakroCare.com
MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS),ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
MakroCare Awarded as:
• Best Biopharmaceutical Regulatory ConsultancyFirm – Global Health & Pharma
• BestPharmaceutical Strategic Development Specialist - UK Enterprises
• TheOutstanding Consulting Firm - Insights Success
• AIExcellence in Regulatory & Automation Solutions - Acquisition International
• AIExcellence in Best Bio Pharma Development Partner - Acquisition International
• BestPractices Award - Clinical Informatics
• NJExcellence Award - US Institute for Excellence in Commerce
• BestBiotech Award - US Commerce Association
• Clinical Research Team and Best Technological Development in ClinicalTrials Finalists - Scrip Awards
• Circle Of Excellence – MerchantCircle
About MakroGroup | www.MakroGrp.com
Makro Group of Organizations established in 1996, Makroprovides a complete range of solutions for every stage of business andinformation lifecycle.
• MakroCare,DDi, MakroTech and MakroScientific are MakroGroup Companies
• DDiAwarded by Insights Success, CIO, Corporate LiveWire, Pharma Tech Outlook,Clinical Informatics & SCRIP
• MakroTech is Awarded 3-time FAST 500 (Deloitte), 3-time INC 5000 company& TOP 100 diversity business in NJ
• MakroFoundation is a Suicide Prevention Helpdesk, part of Makro CSRInitiative, has counseled over 3000 people.