Medical Reviewer-Drug Safety Physician

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 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. If this excites you, then apply below:Job Title: Medical Reviewer – Pharmacovigilance Location: Work from office:Bangalore, Hyderabad, Mumbai, Pune, Delhi Willingness to relocateto one of the above locations is mandatory. Education Requirements: MBBS and MD (mandatory) Candidates without both qualifications will not be considered.Job Title: Medical Reviewer – Pharmacovigilance Location: Work from office:Bangalore, Hyderabad, Mumbai, Pune, Delhi Willingness to relocateto one of the above locations is mandatory.Education Requirements: MBBS, MD(mandatory) Medical council of India registration ( Mandatory)Job Description: As aMedical Reviewer – Pharmacovigilance , you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements. You will play a critical role in safeguarding patient safety through high-quality medical evaluation and regulatory reporting. Key Responsibilities: Perform medical review of ICSRs foraccuracy ,medical relevance , andconsistencywith the source documents and safety database entries, in alignment with client requirements. Conductsecond-level triagingof non-serious cases to identify any potential serious adverse events (SAEs), as per client-specific conventions. Review and validate: Suspect product coding Event selection and MedDRA coding (current version) Grouping/subsuming and event ordering Confirm and correct: Event coding and classification Ranking of events, seriousness criteria, and listedness/expectedness Performcomprehensive medical evaluationof adverse event reports including serious/expedited cases and pregnancy-related reports. Assess adverse events forseriousness ,listedness , andcausality , ensuring all medically relevant data from source documents is accurately reflected. Review and enhancenarrativesin compliance with client conventions. Provide or verify company pharmacovigilance (PV) comments as needed. Initiate appropriate follow-up queries based on the clinical context of the case. Identify and escalate potentialsafety signals or concernsin line with client procedures. Ensure completeness and medical soundness of cases before providingfinal medical sign-off . Assessmalfunctions and serious injury/death outcomesin relation to combination products. Participate inliterature surveillanceandaggregate reportmedical review, ensuring compliance with regulatory timelines and SOPs. Track and document inconsistencies in data entry and provide feedback for continuous improvement. Collaborate closely with cross-functional teams to maintainscientific accuracy ,clarity , andregulatory compliancein all case documentation. Stay updated with international pharmacovigilance regulations and follow all applicableSOPs ,guidelines , andbest practices . Attend mandatory internal and client-specifictrainingsto ensure continuous compliance. Required Skills and Competencies: Stronganalytical and critical thinkingabilities Highattention to detailand scientific accuracy Soundmedical judgmentand decision-making in line with pharmacovigilance standards Proficiency inmedical terminology , disease pathology, pharmacology, and therapeutics Ability toanalyze and interpret adverse event data Strongwritten and verbal communication skills Goodcomprehensionand the ability tosummarize complex medical data Team player with effectiveinterpersonal and collaboration skills Familiarity withpharmaceutical industry practicesanddrug development processes(preferred)Additional Requirements: Willing to relocateto any of the listed office locations. Ready to work from the officewith hybrid options Must possessMBBS and MDdegrees (non-negotiable)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, 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.