Pharma Data Entry Associate
1 - 5 Years
Chennai
Job Description
Position PurposeReview, analysis, preparation, and completion of safety-related reports within scope of the DSU to determine the safety profile of Clients products and to meet regulatory requirements. Provide specific pharmacovigilance knowledge and experience, as required by the business, and mentor colleagues accordingly. Manage resources in the safety team depending on local organization and safety group size.Primary Responsibilities Organize, manage, and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity. Carry out all case management activities as appropriate.Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requestedReview processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenariosEnsure complete and timely forwarding of ICSR to Core Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.Consistently apply regulatory requirements and Client policies Analyze and monitor activities, define and implement corrective actions, where applicable.Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.Provide oversight and team mentoring on case handling aspects, data extraction, and analyses. Manage, where applicable, safety resources in th
Company Profile
Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functionsunderpinned by the worlds largest delivery networkAccenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 373,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com
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