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 relocate to 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 relocate to one of the above locations is mandatory. Education Requirements: - MBBS, MD(mandatory) - Medical council of India registration ( Mandatory) Job Description: As a Medical 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 for accuracy, medical relevance, and consistency with the source documents and safety database entries, in alignment with client requirements. - Conduct second-level triaging of 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 - Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports. - Assess adverse events for seriousness, listedness, and causality, ensuring all medically relevant data from source documents is accurately reflected. - Review and enhance narratives in 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 potential safety signals or concerns in line with client procedures. - Ensure completeness and medical soundness of cases before providing final medical sign-off. - Assess malfunctions and serious injury/death outcomes in relation to combination products. - Participate in literature surveillance and aggregate report medical 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 maintain scientific accuracy, clarity, and regulatory compliance in all case documentation. - Stay updated with international pharmacovigilance regulations and follow all applicable SOPs, guidelines, and best practices. - Attend mandatory internal and client-specific trainings to ensure continuous compliance. Required Skills and Competencies: - Strong analytical and critical thinking abilities - High attention to detail and scientific accuracy - Sound medical judgment and decision-making in line with pharmacovigilance standards - Proficiency in medical terminology, disease pathology, pharmacology, and therapeutics - Ability to analyze and interpret adverse event data - Strong written and verbal communication skills - Good comprehension and the ability to summarize complex medical data - Team player with effective interpersonal and collaboration skills - Familiarity with pharmaceutical industry practices and drug development processes (preferred) Additional Requirements: - Willing to relocate to any of the listed office locations. - Ready to work from the office with hybrid options - Must possess MBBS and MD degrees (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.