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.
Roles and Responsibilities
In this role you are required to identify and assess complex problems for area(s) of responsibility. The individual should create solutions in situations in which analysis requires in-depth knowledge of organizational objectives. Requires involvement in setting strategic direction to establish near-term goals for area(s) of responsibility. Interaction is with senior management levels at a client and/or within Accenture, involving negotiating or influencing on significant matters. Should have latitude in decision-making and determination of objectives and approaches to critical assignments. Their decisions have a lasting impact on area of responsibility with the potential to impact areas outside of own responsibility. Individual manages large teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
Additional Information
Qualification : Any Graduation
Location : Bengaluru
Experience : 10-15 years
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory affairs
End Date : 25th October, 2019
See All M.Pharm Alerts M.Sc Alerts B.Pharm Alerts B.Sc Alerts
See All Other Jobs in our Database
.png)
