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Drug safety physician Jobs in Delhi,Ahmedabad - Client of Grassik

Drug safety physician

Client of Grassik
experience-icon 0 Years
salary-icon Not disclosed
qualification-icon MD
Expired

Posted: 06 May 20

Job Description

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 Required Experience: 

Job Particulars

Role others
Education MD
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id925116
Job Category Others
Locality Address Mathura Road
Country India

About Company

Client of Grassik
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