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Medical Reviewer

2 years years
not specified
10 Sept. 3, 2025
Job Description
Job Type: Full Time Education: Medical Degree (MD or equivalent) required 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 Reviewer

Job Requisition Number: JR - 174630
Location: Gurgaon, Haryana, India
Department: Patient Safety
Date Posted: 08/12/2025


About Baxter

At Baxter, we are united by our mission to save and sustain lives. Our work positively impacts patients across the globe. From hospitals to homes, Baxter’s products and therapies are integral to modern healthcare. With over 85 years of innovation, Baxter offers a purpose-driven, dynamic, and collaborative workplace where employees do their best work.


Position Summary

The Medical Reviewer (MR) is responsible for medical review of individual case safety reports (ICSRs), ensuring appropriate clinical interpretation, and supporting pharmacovigilance processes to comply with global regulatory requirements.


Key Responsibilities

  • Perform medical review of ICSRs:

    • Medical coding

    • Seriousness and expectedness assessment

    • Causality assessment (Baxter-specific)

  • Ensure consistency and appropriate medical interpretation in adverse event assessments.

  • Support preparation of periodic documents (e.g., PSURs, PBRERs, PADERs) and product labels.

  • Provide medical and scientific expertise in pharmacovigilance, ensuring timely and accurate regulatory submissions.

  • Support Safety Operations:

    • Answer case processing team’s medical queries

    • Guide on event coding, conventions, case splitting

  • Maintain up-to-date knowledge of global pharmacovigilance regulations (especially FDA, EMA).

  • Contribute to staff training, mentorship, and continuous medical education.

  • May engage in benefit-risk analysis and safety surveillance:

    • Risk management plans

    • REMS

    • Regulatory assessment responses


Required Qualifications

Education:

  • Medical Degree (MD or equivalent) required

  • Board certification or eligibility

Experience:

  • Minimum 2 years post-residency experience

  • At least 1 year in a pharmaceutical/biotech company

  • Preferred: Experience with regulatory agencies (FDA, EMA, etc.)

  • Understanding of drug safety across pre- and post-marketing stages


Skills and Competencies

  • In-depth knowledge of:

    • Global drug safety regulations

    • Adverse event reporting systems

    • Safety databases and coding dictionaries (e.g., MedDRA, WHOART, COSTART)

  • Strong oral and written communication skills

  • Excellent teamwork and interpersonal abilities

  • Capable of presenting safety-related topics to regulatory authorities or at scientific forums


Workplace & Culture

  • Baxter supports a flexible workplace policy with a minimum 3 days onsite per week.

  • We offer:

    • Dynamic and future-focused environment

    • Additional annual leave

    • A strong, value-driven organizational culture


Equal Opportunity Employment

Baxter is an equal opportunity employer and evaluates applicants without regard to:

  • Race, color, religion, gender, age, sexual orientation, gender identity, national origin, veteran status, or disability.

Reasonable accommodations are provided to applicants with disabilities. If needed, please click here to request support during the application or interview process.


Recruitment Fraud Notice

Beware of employment scams. Baxter does not request personal or financial information via unauthorized channels. For more, review our Recruitment Fraud Notice.


How to Apply

Click the "Apply Now" button on the job posting page.


Office Address

Baxter (India) Pvt. Ltd.
5th Floor, Tower A, Building No. 9
DLF Cyber City, DLF Phase III
Gurgaon - 122002, Haryana, India