Medical Reviewer

1+ years

Not Disclosed

Gurgaon

10 Dec. 18, 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

Medical Reviewer - Baxter
Req # JR - 150969
Location: Gurgaon, Haryana, India
Job Category: Patient Safety
Date Posted: 11/25/2024

About Baxter:

At Baxter, we are deeply connected by our mission of saving and sustaining lives. Our work positively impacts millions of patients globally. For over 85 years, Baxter has been at the forefront of medical innovations transforming healthcare. Our products and therapies are found in hospitals, clinics, and homes worldwide. At Baxter, we create an environment where success, happiness, and inspiration thrive. Join us and make an impact where your work accelerates our mission.

Position Summary:

The Medical Reviewer (MR) will provide medical review for individual case safety reports (ICSRs), ensuring that appropriate medical interpretation, coding, and consistency are applied to adverse event assessments. This role also involves supporting the Safety Operations team with pharmacovigilance expertise and contributing to periodic document review and regulatory submissions.

Essential Duties and Responsibilities:

Provide medical and scientific expertise for adverse event case assessment, ensuring consistency and appropriate interpretation.
Review and analyze individual case safety reports for coding, seriousness, expectedness, and Baxter’s causality assessment.
Support the Safety Operations team by offering expertise on medical queries, coding events, and case splitting.
Maintain up-to-date knowledge of global regulatory authority regulations, especially FDA and EMA.
Participate in safety surveillance activities, including safety signal detection, risk management plans, and benefit-risk safety analysis.
Contribute to the preparation of periodic documents such as PSURs, PBRERs, and PADERs.
Train and provide leadership and continuing education for departmental staff.
Collaborate with regulatory authorities on safety-related matters.

Qualifications:

Medical degree (or equivalent) with board certification/eligibility required.
Minimum of two years post-residency experience, with at least one year in the pharmaceutical or biotechnology industry.
Knowledge of adverse event case triage processing and safety coding dictionaries (e.g., MedDRA, WHOART).
Strong oral and written communication skills.
Experience working with FDA, EMA, or other regulatory authorities preferred.
Familiarity with national and international regulatory guidelines.

Education and Experience:

Medical degree required.
At least two years of experience post-residency, with at least one year in the pharmaceutical/biotechnology industry.
Exposure to working with FDA, EMA, or other regulatory authorities is an advantage.

Additional Information:

Baxter offers a dynamic and flexible work environment, with a minimum of 3 days a week onsite for collaboration. We are committed to supporting the needs for flexibility in the workplace through our flexible workplace policy.

Equal Employment Opportunity:

Baxter is an equal opportunity employer and evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

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