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
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Brazil | Sao paulo |Attica :
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Madrid |Cebu Province :
Cebu City |Philippines :
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Croatia |Zagreb :
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