Job Skill: Regulatory affairs
Designation: Career Level - 10-Analyst
Job Location: Chennai
Qualifications: Any Graduation
Years of Experience: 5-7 years
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You will be aligned with our Pharmaceuticals Processes vertical and help us with the processes to collect, monitor, research, assess and evaluate information on the adverse effects of medication with a view to identifying new information about hazards associated with medicines and consequently, prevent harm to patients. It also deals with the reviewing and resolving of discrepancies identified by the system or through manual checks as per guidelines. Employees under this span can also be responsible for a number of activities related to the design, development, and maintenance of Clinical Database objects.
You will be working as a part of Pharmacovigilance team which designs and maintains a safety database to monitor single case support activities; source distribution for business partners and to perform medical literature searches. Responsible for data entry, MedDRA coding and label assessment of adverse event in SUSAR cases. If there are issues with the provided information, scientist is contacted for verification.
You will be responsible for Regulatory affairs where in you will be accountable for the design, development and delivery of business solutions related to the regulatory review and approval of pharmaceutical drugs and perform publishing and quality control tasks on submission components. You will be creating and maintaining project documentation including: meeting agendas, meeting minutes, issues and status reports internally and externally.
Good to have skills: Regulatory affairs,Good communication skills
Roles and Responsibilities
In this role you are required to do analysis and solving of increasingly complex problems. Interaction is with peers within Accenture before updating supervisors. Likely has some interaction with clients and/or Accenture management. Minimal instruction on daily work tasks and a moderate level of instruction on new assignments will be provided. Decisions made by you impact your own work and may impact the work of others. In this role the person would be an Individual contributor and/or oversees a small work effort and/or team
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