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Job Title - Medical Reviewer

Location: Gurgaon / Ahmedabad

Summary:

The Medical Reviewer (MR) is responsible for:

Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, Baxter causality assessment. Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment.Potential review of periodic documents, and product labels.

Essential Duties and Responsibilities:

Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment.Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities.Support the Safety Operations team, providing expertise for the case processing team for medical questions e.g., coding of events, understanding coding conventions, splitting of cases etc.Maintain knowledge of global regulatory authority regulations (especially FDA and EMA).Contribute to the training, leadership and continuing education for all departmental staff.May perform benefit-risk safety analysis, including: safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans and REMS, Regulatory Authority assessment reports and queries, and periodic documents, such as PSURs, PBRERs, and PADERs.

Qualifications:

Knowledge of industry regulations and drug safety practices globally. Knowledge of adverse event case report triage processing.Experience with commercial databases and safety coding dictionaries (MedDRA, WHOART, COSTART, etc.).Excellent oral and written communication skills.Excellent teamwork and interpersonal skills are required.Strong skills in presenting drug safety topics for regulatory authorities or at conventions, meetings, etc.

Education and/or Experience:

A medical degree (or equivalent) and board certification/eligibility are required.Two years of experience post-residency, with at least one year of experience in pharmaceutical/biotechnology company.Exposure to working relationship with FDA, EMA, or other regulatory authorities is preferred.Knowledge and understanding of national and international regulatory guidelines are a plus.Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice.

At Baxter, we offer a dynamic and future focused work environment offering workplace flexibility, additional annual leave and a strong value driven culture.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

EEO (Equal Employment Opportunity)

Baxter is an equal opportunity employer. Baxter 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.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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