Job title: Regulatory Affairs Officer

Company: IQVIA

Job description: JOB DESCRIPTION Global Regulatory Labeling Specialist: . Maintain the Company Core Data Sheet (CCDS) including Core Safety Information (CSI), including periodic review and update, throughout the lifecycle of the medicinal products . Labeling content

JOB DESCRIPTION Global Regulatory Labeling Specialist: . Maintain the Company Core Data Sheet (CCDS) including Core Safety Information (CSI), including periodic review and update, throughout the lifecycle of the medicinal products . Labeling content gap analysis by performing multiple label comparisons . Screening medical and scientific literature to substantiate safety and efficacy content . Review of internal and external safety/efficacy documents like Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), Signal Evaluation Reports (SER), Clinical Overviews (CO) & HA Safety notifications, and follow up on potential CCDS/CSI changes . Organize and lead cross functional labeling discussions to reach consensus on global labelling matters and prepare supporting documents for CCDS changes. . Ensure that the CCDS content is implemented into the Local Product Information (Prescriber and patient information) within required timelines, for multiple markets . Preparation of global and customized local justification documents/addendum to clinical overviews (ACO) in coordination with medical writers . Coordinate the preparation of label translations, responses to Health Authority (HAs) or Local Operating Companies (LOCs) queries relating to labelling content Qualifications . Master’s Degree Degree in Lifescience or related discipline Req . With at least 2 years of relevant labeling experience . Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate . Good, solid interpersonal communication (oral and written) and organisation skills . Ability to establish and maintain effective working relationships with coworkers, managers and clients . Strong software and computer skills, including Microsoft Office . Demonstrates self-motivation and enthusiasm . Ability to work on several projects, with direction from senior staff as appropriate . Ability to follow standard operating porcedures consistently provides independent thought to assist in process improvements . Ability to make decisions on discrete tasks under senior supervision . Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education . Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

Expected salary:

Location: Bangalore, Karnataka

Job date: Thu, 25 Aug 2022 22:08:53 GMT

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