Job Title: Drug Safety Analyst    

Location(s): Pune, India  

About Springer Nature

Springer Nature is one of the leading publishers of research in the world. We publish the largest number of journals and books and are a pioneer in open research. Through our leading brands, trusted for more than 180 years, we provide technology-enabled products, platforms and services that help researchers to uncover new ideas and share their discoveries, health professionals to stay at the forefront of medical science, and educators to advance learning. We are proud to be part of progress, working together with the communities we serve to share knowledge and bring greater understanding to the world. For more information, please visit about.springernature.com and follow @SpringerNature.

About the Brand

AdisInsight Safety provides tools to help pharma customers stay on top of their in-house pharmacovigilance (PV) literature monitoring. It provides comprehensive coverage of the literature for valid ICSRs and special situations across all drugs, collating information and data from global biomedical reference databases, in line with regulatory guidelines and industry best practice.

AdisInsight Safety delivers comprehensive, high-quality safety intelligence by leveraging a cutting-edge, automated content acquisition process that blends advanced AI/ML technologies with expert human validation. This future-ready approach minimizes human error, ensures adaptability to evolving regulatory requirements, and enables the integration of diverse data sources. Users benefit from expanded access to safety-related content that is clearly categorized and easily filterable—making it simple to find the precise information needed for informed decision-making.

About the Role

The Drug Safety Analyst validates AI-generated safety content derived from biomedical literature as well as providing research, analysis and technical support for product development and continual improvement of Pharma Solutions safety products.

The role is ideal for an established PV professional who wants to apply their skills and experience in a different setting, contributing to ongoing product quality and delivery as well as product development in the drug safety space, and continuing to help drive global patient safety.      

Role Responsibilities:

• Evaluates & validates AI-derived or published drug safety content in the regular and evolving production process, applying Scientific Comprehension and Pharmaceutical Industry Knowledge
• Conducts technical and domain research to create product & business value, identifying opportunities by linking domain & technical facts to broader business perspective through Customer Focus, Pharmaceutical Industry Knowledge and being Data Domain Savvy
• Communicates Effectively and Manages Complexity to clearly articulate product development issues and opportunities in discussions, presentations or documentation, keeping stakeholders focused on the key points.   
• Contributes to Collaboration, shows Adaptability and Cultivates Innovation to enable continuous learning and improvement through shared reflection on processes and outcomes
• Drives Results by seeking new ways to optimize efficiency, quality and effectiveness

Experience, Skills & Qualifications:

Essential

• Masters or above in Pharmacy/LifeSciences/Medicine
• 3-5 years’ experience in PV or related drug safety discipline
• Candidates with significant experience in signal detection and management are preferred
• Strong understanding of PV workflows and fundamental principles of:
  • Case processing, ICSR criteria and application to medical literature, MedDRA coding etc
  • Signal identification and validation, disproportionality analysis, signal prioritization and evaluation, benefit-risk assessment and risk management
  • Aggregate safety reporting
  • Regulatory reporting requirements and compliance needs
• Logical & critical thinking, analytic skills, literature review capabilities
• Able to conduct technical domain research, identify issues, trends and opportunities
• Can link technical facts to broader perspectives (business, product, operations) and articulate implications and opportunities
• Strong English-language and scientific expression skills
• Able to conduct data/content checks with good attention to detail
• Self-motivation and enthusiasm with a collaborative attitude

Ability to work independently with minimal/no supervision when needed 

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