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.
Main Responsibilities:
- 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.