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Lead - Scientific Writing

3+ years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: M.B.B.S/MD/MS/DNB Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

πŸ“Œ Lead - Scientific Writing | Indegene
πŸ“ Location: Bangalore, KA, India
πŸš€ Join a Global Leader in Healthcare & Technology

🌟 About Indegene

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.

πŸ“ About the Role

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.

πŸ” Key Responsibilities

βœ” Medical Review & Pharmacovigilance: Assess seriousness, expectedness, and causality of adverse events for investigational and marketed products.
βœ” Literature Surveillance & Signal Management: Identify potential safety signals, validate risks, and provide insights for aggregate reports.
βœ” Regulatory Safety Reporting: Conduct medical review of ICSRs, PBRERs, DSURs, SUSARs, PADERs, PAERs, RMPs, and ad-hoc safety reports.
βœ” Risk-Benefit Evaluation: Provide medical insights to strengthen risk management planning.
βœ” Client Interaction: Work closely with global stakeholders to meet expectations and ensure medical accuracy.
βœ” Compliance & Quality: Maintain data integrity, reduce errors, and enhance efficiency in safety deliverables.

πŸ“‹ Qualifications

πŸŽ“ Medical Degree (M.B.B.S/MD/MS/DNB) required.
πŸ“Œ 3+ years of experience in Pharmacovigilance, Clinical Assessment, or Hospital/Pharmacy settings.
πŸ“Œ 1+ year of Medical Review of Aggregate Reports preferred.
πŸ“Œ Strong understanding of global drug regulations, documentation, and regulatory guidelines.
πŸ“Œ Proficiency in document management systems & safety databases.
πŸ“Œ Excellent analytical, decision-making, and communication skills.

πŸ’Ό Why Join Indegene?

🌏 Fast-growing global organization at the forefront of healthcare & technology.
πŸ“ˆ Entrepreneurial work culture with accelerated career growth opportunities.
🀝 Diversity & Inclusion: Equal Opportunity Employer supporting workplace equity.
🎯 Work on cutting-edge medical innovations that impact global healthcare.

πŸ“© Ready to Make an Impact? Apply Today!