Research Associate Senior 2+Yrs

Description:

Job Title - Medical Reviewer

Location: Gurgaon

Summary:

The Medical Reviewer (MR) is responsible for:

• Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, client 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.