Safety Physician

Fortrea

2+ years

Not Disclosed

Pune

10 Sept. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Fortrea

Fortrea, a leading global Contract Research Organization (CRO), is dedicated to scientific excellence and boasts decades of experience in clinical development. We provide a comprehensive array of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a team of over 19,000 professionals operating in more than 90 countries, Fortrea is at the forefront of transforming drug and device development for partners and patients worldwide.

Job Overview

We are seeking a highly skilled Medical Safety Expert to join our team. This role will involve providing critical medical safety expertise to sponsors of drugs, devices, and combination products during the post-marketing period.

Summary of Responsibilities

Conduct primary medical reviews of cases, including assessing seriousness, listedness/labeling, causality, adverse event coding, and narrative review.
Update and document case data daily in relevant trackers and tools to facilitate efficient tracking and workflow management.
Take full responsibility for assigned deliverables, ensuring they meet quality, compliance, and productivity standards as per SLAs and KPIs.
After one year of tenure, provide training and guidance to the case processing team on medical aspects of case processing.
Perform secondary medical reviews (QC role) and retrospective case reviews (QA role) after one year of tenure, focusing on quality, error trends, training needs, and process improvements.
Engage in aggregate medical review and signal detection/analysis activities as required.
Enhance client relationships and contribute to a high level of customer service.
Participate in and contribute to process improvement initiatives across the company.

Why Join Us?

At Fortrea, we are driven by a passion for overcoming challenges in clinical trials. Our commitment is to revolutionize the development process, accelerating the delivery of transformative therapies to patients. We offer a collaborative and nurturing work environment where personal growth is supported, allowing you to make a significant global impact.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer committed to diversity and inclusion. We do not tolerate harassment or discrimination of any kind and make employment decisions based on business needs and individual qualifications. We welcome applications from all individuals regardless of race, religion, color, national origin, gender (including pregnancy and medical conditions), family or parental status, marital status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

For more information on how we collect and store your personal data, please refer to our Privacy Statement.

For More Information

To learn more about Fortrea and our groundbreaking work in clinical trials, please visit www.fortrea.com.

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Safety Physician

Job Description

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