π Lead - Scientific Writing | Indegene
π Location: Bangalore, KA, India
π Join a Global Leader in Healthcare & Technology
At Indegene, we’re redefining healthcare solutions through technology-driven innovation. Our entrepreneurial culture fosters bold, industrious, and nimble talent—offering global career growth opportunities at the intersection of healthcare and technology.
We are seeking an experienced Medical Reviewer to join our Pharmacovigilance & Safety Team. This role involves performing medical review and oversight of key safety deliverables, ensuring compliance with global regulations, SOPs, and reporting timelines.
β Medical Review & Pharmacovigilance: Assess seriousness, expectedness, and causality of adverse events for investigational and marketed products.
β Literature Surveillance & Signal Management: Identify potential safety signals, validate risks, and provide insights for aggregate reports.
β Regulatory Safety Reporting: Conduct medical review of ICSRs, PBRERs, DSURs, SUSARs, PADERs, PAERs, RMPs, and ad-hoc safety reports.
β Risk-Benefit Evaluation: Provide medical insights to strengthen risk management planning.
β Client Interaction: Work closely with global stakeholders to meet expectations and ensure medical accuracy.
β Compliance & Quality: Maintain data integrity, reduce errors, and enhance efficiency in safety deliverables.
π Medical Degree (M.B.B.S/MD/MS/DNB) required.
π 3+ years of experience in Pharmacovigilance, Clinical Assessment, or Hospital/Pharmacy settings.
π 1+ year of Medical Review of Aggregate Reports preferred.
π Strong understanding of global drug regulations, documentation, and regulatory guidelines.
π Proficiency in document management systems & safety databases.
π Excellent analytical, decision-making, and communication skills.
π Fast-growing global organization at the forefront of healthcare & technology.
π Entrepreneurial work culture with accelerated career growth opportunities.
π€ Diversity & Inclusion: Equal Opportunity Employer supporting workplace equity.
π― Work on cutting-edge medical innovations that impact global healthcare.
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