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Doctor-drug Safety Physician/ Medical Safety Adviser

Davangere, Karnataka

Kelly Services India Pvt Ltd

Job Description

Report preparation [e.g. Periodic Safety Update Reports (PSURs), Addendum PSURs, Bridging Reports, PSUR Line Listings, US PADERs] from aggregate data for products, in accordance with client conventions and requirements;
Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses, Drug Safety Reports , review of published literature and case listings; Vigilance over important/designated medical events;
Interaction with client personnel to discuss potential signals and issues detected with products; Support preparation and maintenance of Risk Management Plans;
Follow-up and interaction with clients to obtain incomplete/missing information, with a view to resolving and clarifying issues;
Performing medical review of individual case safety reports (ICSRs); performing medical review of narratives for Clinical Study Reports (CSRs);
Providing medical advice to drug safety scientists to assist them with processing of ICSRs and CSR narratives;
Maintaining an excellent knowledge of the adverse event safety profile of assigned drugs, labelling documents, and client guidelines and Standard Operating Procedures (SOPs);
Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for report submissions;
Maintaining records in compliance with guidelines and SOPs

Company Description

About Kelly Services - US Fortune 500 Company (TOP 6 Outsourcing company in the world)Kelly... Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion.   Read full description

Additional Information

Last updated:
09/05/2019
Job type:
Full time
Position type:
Permanent
Vacancies:
3
Minimum experience:
One year
Education:
Compulsory Education
Salary range:
₹ 9,00,000 - ₹ 16,00,000 / Yearly (Gross Pay)
Category:
Jobs in IT - Software Programming / Analysis
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