Pharmacovigilance-regulatory Affairs

1 - 3 Years
Bengaluru
Not Disclosed by Recruiter

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Posted: 8 days agoOpenings: 1Job Applicants: 958+Job Views: 2057+

Job Description

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 solve routine problems, largely through pre cedent and referral to general guidelines. Expected interaction is within own team and direct supervisor. Detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments would be provided. Decisions impact own work. Individual contributor as a part of a team, with a predetermined, focused scope of work.

Salary: Not Disclosed by Recruiter

Industry:IT-Software / Software Services

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:R&D

Role:Bio/Pharma Informatics-Associate/Scientist

Employment Type:Full Time, Permanent

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

PG:Post Graduation Not Required

Doctorate:Doctorate Not Required

Company Profile

Accenture Solutions Pvt Ltd

Accenture is a leading global professional services company, providing a broad range of services in strategy and consulting, interactive, technology and operations, with digital capabilities across all of these services. We combine unmatched experience and specialized capabilities across more than 40 industries - powered by the world's largest network of Advanced Technology and Intelligent Operations centers. With 505,000 people serving clients in more than 120 countries, Accenture brings continuous innovation to help clients improve their performance and create lasting value across their enterprises.
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Recruiter Name:HR

Contact Company:Accenture Solutions Pvt Ltd

Reference Id:19449

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