Accenture is a global management consulting, technology services and outsourcing company, with approximately 275,000 people serving clients in more than 120 countries. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world’s most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. The company generated net revenues of US$28.6 billion for the fiscal year ended Aug. 31, 2013.
Post : Pharmacovigilance - Regulatory affairs
Job Summary
• 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
Roles and Responsibilities
In this role you are required to do analysis and solving of moderately complex problems. May create new solutions, leveraging and, where needed, adapting existing methods and procedures. The person would require understanding of the strategic direction set by senior management as it relates to team goals. Primary upward interaction is with direct supervisor. May interact with peers and/or management levels at a client and/or within Accenture.
Additional Information
Qualification : Any Graduation
Location : Chennai
Experience : 7-8 years
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory affairs
End Date : 25th December, 2019
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