Safety Physician

3+ years

Preferred by Comapny

Pune

11 Nov. 24, 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

Job Title: Medical Safety Expert

Location: Pune, India
Posted On: [Date not provided]

Company Overview

Fortrea is a leading global contract research organization (CRO) renowned for its scientific rigor and clinical development expertise. We provide a wide range of services to pharmaceutical, biotechnology, and medical device companies across more than 20 therapeutic areas. With operations spanning over 90 countries, Fortrea is committed to transforming drug and device development, making a significant impact on global healthcare.

Job Overview

Fortrea is seeking a Medical Safety Expert to provide medical safety expertise in the post-marketing period for sponsors of drugs, devices, and combination products. The role focuses on the medical review and analysis of adverse event data, ensuring high-quality deliverables and compliance with industry standards.

Key Responsibilities

Primary Medical Review:
- Conduct medical reviews of adverse event cases, including assessments for seriousness, listedness/labeling, causality, adverse event coding, and narrative reviews.
Data Management:
- Update and document case data daily, using appropriate trackers/tools to facilitate tracking and workflow management.
Deliverable Responsibility:
- Ensure that all assigned deliverables meet quality, compliance, and productivity SLAs (Service Level Agreements) and KPIs (Key Performance Indicators).
Training and Guidance:
- Provide training and guidance to the case processing team on medical aspects of case processing after one year of tenure.
Secondary Medical Review:
- Perform secondary medical review (QC role) and retrospective reviews (QA role) of cases to measure quality, identify error trends, training needs, and areas of improvement after more than one year of experience.
Signal Detection and Analysis:
- Conduct aggregate medical reviews and signal detection/analysis activities as required.
Client Relationship Management:
- Enhance existing client relationships whenever possible and maintain a high level of customer service.
Process Improvement:
- Participate in process improvement activities across the company to optimize workflows and enhance overall service delivery.

Qualifications & Experience

Education:
- Bachelor's degree or equivalent in a relevant field (e.g., Medicine, Life Sciences).
Experience:
- At least 1 year of experience in medical review or related roles in the healthcare or pharmaceutical industry.
Skills:
- Strong knowledge of adverse event case processing and medical terminology.
- Ability to work with medical data tracking systems and tools.
- Strong attention to detail, analytical skills, and ability to meet deadlines.
- Excellent communication skills, both verbal and written.
- Proven ability to work effectively in a collaborative, team-oriented environment.

Why Join Fortrea?

Fortrea is committed to overcoming barriers in clinical trials and revolutionizing the development process. As a part of our team, you will contribute to the swift delivery of life-changing therapies to patients in need. We offer a collaborative workspace where personal growth is nurtured, providing you with the opportunity to make a meaningful global impact.

Fortrea is an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea promotes diversity and inclusion and does not tolerate any form of harassment or discrimination. Employment decisions are based on the needs of the business and individual qualifications, ensuring equal opportunity for all.

For more information about Fortrea, visit: www.fortrea.com

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Safety Physician

Job Description

Job Title: Medical Safety Expert

Company Overview

Job Overview

Key Responsibilities

Qualifications & Experience

Why Join Fortrea?

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