Title:  Senior Drug Safety Physician

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven.  We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

• Medical evaluation of adverse event reports, including but not limited to all serious and

expedited reports and all pregnancy reports.

• Provide medical guidance and opinions to drug safety associates, other physicians and scientific staff in the evaluation and follow-up of individual case safety reports.
• Responsible for medical review of ICSRs for accuracy, medical relevance, and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement
• Categorize and document the QC observations as per the checklist
• Responsible for causality assessment for all drugs, including vaccines.
• Evaluate adverse event report for seriousness, listedness, corrects coding of the adverse event and ensures that all medically relevant information from the source documents are included, provide final check of the case and provide medical sign off on the case.
• Responsible for following international pharmacovigilance regulations, company and department SOPs and department and function working practices.

Your impact:
About you: You will perform medical review of ICSR in ARGUS safety database and also review literature article for case validity and seriousness criteria.

Must have: MBBS or equivalent qualification with minimum 2 years of experience in performing medical review of ICSRs

Nice to have: Experience in reviewing AE coding, listedness assessment, causality and assessment of ICSR and literature articles for case validity.

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.