MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.

www.makrocare.com

Top primary skills required for this role:

• Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, knowledge of MS-Office products such as Excel, Word.
• Sound awareness of all relevant regulations, including GCP.        

Secondary skills required for this role:

• Ability to organize and plan tasks
• Shows commitment to and performs consistently high quality work
• Excellent interpersonal, verbal and written communication skills.
• Sense of urgency in completing assigned tasks.

Tertiary skills required for this role:

• Plans and delivers verbal and written communications that persuade the intended audience.
• Sense of urgency in completing assigned tasks. 

Any other specifications:

• Should have experience in leading the projects and able to communicate to client directly whenever required.   

•   Responsible for Coding Adverse Events and Concomitant diagnosis using the current version of MedDRA as distributed by MSSO and in accordance to the Client specific SOP's.

• Coding of Medical data in a timely manner.

• Ensure Critical studies with consistent coding and handling issues.

• Coordination of import or export of data for coding and transfer of data/coded terms to clients.

• Review listing for coding terms to ensure accuracy and consistency of coded data.

• Consistent with client guidelines and regular checks for feedback's.

• Authenticate accuracy of Terms Processed and maintaining the safety compliance, also ensuring quality standard.

• Documenting the observations on an internal generated Quality check sheets (quality control form, defect tracker).

• Providing regular feedback to the team members for continuous improvement of the process.

• Maintain and Update daily metrics.

• To make sure all the priority study terms are processed on priority.

• Secondary quality Checks of Serious Spontaneous Adverse Events / Post Marketing adverse event / Clinical trial and invalid terms.

•  Maintain knowledge on updates or changes in medical coding dictionary versions.