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Medical Reviewer

3-5 years
Not Disclosed
11 Nov. 23, 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

Job Description

This is where you save and sustain lives.
At Baxter, our mission connects us deeply. Every role at Baxter contributes to a positive impact on people worldwide. With a sense of purpose embedded throughout the organization, our work improves outcomes for millions of patients.

For over 85 years, Baxter has pioneered medical innovations that transform healthcare. Our products and therapies are present in almost every hospital, clinic, and home globally. Together, we create an inspiring environment where you can do your best work, fostering happiness and success in each other.

Join us at the intersection of saving and sustaining lives—where your purpose drives our mission forward.


Job Title: Medical Reviewer

Location: Gurgaon / Ahmedabad


Summary

The Medical Reviewer (MR) ensures medical interpretation and consistency in assessing individual case safety reports. Responsibilities include:

  • Reviewing and coding adverse event cases for seriousness, expectedness, and Baxter causality assessment.
  • Supporting periodic document review and product label updates.

Essential Duties and Responsibilities

  • Ensure appropriate medical interpretation and consistency in adverse event case assessment.
  • Provide medical and scientific expertise in pharmacovigilance for timely and accurate regulatory submissions.
  • Support the Safety Operations team with medical insights, including coding conventions and case splitting.
  • Maintain knowledge of global regulations, especially those of the FDA and EMA.
  • Contribute to staff training, leadership, and continuing education in pharmacovigilance.
  • Conduct benefit-risk safety analysis, including safety surveillance, aggregate safety data review, and risk management plans. Tasks may include preparing REMS, PSURs, PBRERs, and PADERs.

Qualifications

  • Comprehensive knowledge of global industry regulations and drug safety practices.
  • Experience in adverse event case triage processing.
  • Proficiency with commercial databases and safety coding dictionaries such as MedDRA, WHOART, and COSTART.
  • Excellent oral and written communication skills.
  • Strong teamwork, interpersonal, and presentation skills, particularly in regulatory or professional settings.

Education and Experience

  • Medical degree (or equivalent) and board certification/eligibility required.
  • At least two years of post-residency experience, with one year in a pharmaceutical or biotechnology company.
  • Exposure to working relationships with FDA, EMA, or other regulatory authorities preferred.
  • Knowledge of global regulatory guidelines and drug safety practices, both pre- and post-marketing.

Work Environment

Baxter offers a dynamic, future-focused workplace emphasizing flexibility. Our policy requires a minimum of three onsite days weekly to foster collaboration and connection, aligned with our mission.

We also provide:

  • Additional annual leave.
  • A strong value-driven culture.

Equal Employment Opportunity

Baxter is an equal opportunity employer, evaluating applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability, or other legally protected characteristics.

Reasonable Accommodations:
Baxter is committed to accommodating individuals with disabilities. If you require assistance during the application or interview process due to a medical condition or disability, please contact us via the provided link, detailing your request and contact information.