Job Description
Job Title: Lead - Scientific Writing
Date Posted: 22 February 2025
Location: Bangalore, KA, India
About Indegene:
Indegene is a technology-driven healthcare solutions provider committed to enabling healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for bold, industrious, and nimble talent. With Indegene, you’ll experience a career that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy.
We invite you to explore exciting opportunities at the convergence of healthcare and technology. To learn more, visit careers.indegene.com.
Role Overview:
We are looking for an ambitious and energetic Lead - Scientific Writing to join our team. This is a key position where you’ll play an instrumental role in overseeing medical writing deliverables and ensuring high-quality documentation in line with global regulatory requirements.
Key Responsibilities:
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Medical Review & Pharmacovigilance:
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Perform medical reviews, including assessment of seriousness, expectedness/listedness, and causality of adverse events for investigational and marketed products.
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Ensure compliance with reporting timelines and quality standards across pharmacovigilance activities, including ICSRs, literature surveillance, and signal management.
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Oversight & Reporting:
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Lead medical review and provide oversight for periodic aggregate reports (e.g., PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs).
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Ensure medical and clinical integrity of data by reviewing and interpreting safety data from various sources.
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Risk Management:
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Contribute to the preparation of safety surveillance strategies and risk management planning.
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Participate in safety assessments, risk/benefit evaluations, and provide medical input at all stages of safety deliverables.
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Client Interaction & Training:
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Interface regularly with clients to meet expectations.
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Participate in relevant training programs and mentor junior team members.
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Operational Efficiency:
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Contribute to reducing costs, cycle time, and error rates in projects.
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Qualifications:
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Education: Medical degree (M.B.B.S/MD/MS/DNB)
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Experience: Minimum of 3 years of relevant experience in pharmacovigilance, hospital, or pharmacy settings, with at least 1 year of experience in medical review of aggregate reports.
Required Skills:
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Strong knowledge of regulatory documentation, drug development processes, and global regulations and guidelines.
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Familiarity with document management systems and relevant applications such as Excel and Outlook.
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Excellent written and verbal communication skills.
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Strong organizational, time management, attention to detail, and decision-making skills.
Nice to Have:
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Strong interpersonal skills and the ability to adapt to varying environments.
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Mentoring experience to guide and support junior team members.
Equal Opportunity Employer:
Indegene is proud to be an Equal Employment Employer, committed to fostering a culture of inclusion and diversity. We do not discriminate on the basis of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic. All employment decisions are based on the business needs, merit, and qualifications of the candidate.
Contact Information:
For more details or to apply, visit Indegene Careers.
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