Medical Physician Specialist I

Fortrea

0-2 years

Not Disclosed

Mumbai Pune

10 March 19, 2025

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 – Post-Marketing

Company: Fortrea, a Global Contract Research Organization (CRO)

Location: [Insert Location]

About Fortrea:

Fortrea is a leading global contract research organization (CRO) providing comprehensive clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in approximately 100 countries, Fortrea is dedicated to transforming drug and device development for partners and patients globally.

Job Overview:

Fortrea is seeking a Medical Safety Expert to provide medical safety expertise to sponsors of drugs, devices, and combination products in the post-marketing period. This role involves the medical review of adverse event cases, regulatory compliance, training of team members, and ongoing support of safety-related processes.

Key Responsibilities:

Perform primary medical review of cases, including assessing seriousness, listedness/labeling, causality, adverse event coding, and narrative review.
Document and update case data and feedback in appropriate tracking tools to ensure smooth workflow management.
Take responsibility for all assigned deliverables, ensuring adherence to quality, compliance, and productivity standards (SLAs/KPIs).
Provide training and guidance to the case processing team on medical aspects of case processing after a tenure of one year.
Conduct aggregate and signal analysis activities, supporting single case processing as required.
Foster a high standard of customer service and accountability within the team.

Qualifications:

Required Education:
- Bachelor’s degree in Medical Science, MD, DO, or equivalent.
- Relevant and equivalent experience may be considered in lieu of educational requirements.
Language Skills:
- Speaking: English (ILR level 3+ or higher).
- Writing/Reading: English (ILR level 4+ or higher).
Experience:
- Working knowledge of medical sciences, diagnosis, therapeutics, and drug treatments.
- Understanding of regulatory requirements for clinical research.
- Familiarity with ICH-GCP guidelines.
Preferred Qualifications:
- 1 to 2 years of clinical practice experience.

Physical Demands/Work Environment:

Office or home-based environment, as requested by the line manager.

Why Join Fortrea?

Fortrea is committed to solving challenges in clinical trials and improving patient access to new therapies. By joining our team, you'll be part of a global organization focused on innovative drug and device development and an inclusive, collaborative work culture.

Fortrea is an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea values diversity and inclusion in the workplace and does not tolerate discrimination or harassment. We make employment decisions based on business needs and individual qualifications without regard to race, religion, color, national origin, gender, sexual orientation, age, veteran status, disability, or any other legally protected characteristic.

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

If you require a reasonable accommodation for the application process or interviews due to a disability, please contact: taaccommodationsrequest@fortrea.com.

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Medical Physician Specialist I

Job Description

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