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Full-time
bachelor degree, postgraduate degree
Posted 45d ago
Apply by Jun 30
~40 hrs/week
Remote in Mumbai, Mahārāshtra, India
Responsibilities
Provide medical safety expertise for drugs and devices by performing primary and secondary medical reviews of cases. Responsibilities include assessing seriousness, causality, and coding while ensuring compliance with quality and productivity SLAs.
Requirements
Requires a Bachelor's degree in medical science, MD, or DO with working knowledge of medical sciences and ICH-GCP guidelines. Preferred candidates have up to one year of pharmaceutical industry experience and 1-2 years of clinical practice.
Full job description
Job Overview:
Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period.
Summary of Responsibilities:
Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review.
Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management.
Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.
Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year.
Performs secondary medical review (QC role) and retrospective review of cases reviewed (QA role), as required for measuring quality of deliverables, identifying error trends, training needs and areas of improvement only after a tenure of greater than 1year.
Performs aggregate medical review and signal detection/analysis activities, as required.
Bringing life-changing benefits to patients faster
Industry
Biotechnology Research
Company size
10,001+ employees
Headquarters
Research Triangle Park, NC
LinkedIn followers
249,917
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.
Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas.
Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.
Together, exceptional is possible.
Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
clinical researchclinical trialsand medical device trialsHealth CareClinical Trials
Bringing life-changing benefits to patients faster
Industry
Biotechnology Research
Company size
10,001+ employees
Headquarters
Research Triangle Park, NC
LinkedIn followers
249,917
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.
Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas.
Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.
Together, exceptional is possible.
Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
clinical researchclinical trialsand medical device trialsHealth CareClinical Trials