Manager, Clinical and Safety Analytics
Location: Hyderabad, Telangana, India
Job Requisition ID: R1591383
Company: Bristol Myers Squibb
About the Role
The Manager, Clinical and Safety Analytics is responsible for developing and enhancing data analytics frameworks within the Worldwide Patient Safety and Pharmacovigilance (PV) Center of Excellence Analytics function. This role focuses on leveraging compliance, clinical, and real-world data to generate insights that support informed decision-making, improve operational efficiency, and strengthen regulatory compliance across BMS REMS and Clinical Analytics programs.
Key Responsibilities
Data Analytics and Reporting
Develop and enhance analytical reporting frameworks using clinical and safety data.
Design, maintain, and optimize dashboards, reports, and analytics applications using Tableau, Spotfire, Excel, and related tools.
Leverage internal data systems to automate reporting processes and reduce manual data retrieval.
Analyze large datasets to identify trends, generate insights, and provide actionable recommendations.
Develop, run, and maintain routine and ad-hoc reports for leadership and stakeholders.
Present analytical findings and business insights to management teams and key stakeholders.
Clinical and Safety Analytics
Support compliance with regulatory requirements and drug safety standards through quantitative and qualitative analyses.
Collaborate with cross-functional teams including Regulatory Affairs, Medical Affairs, Clinical Safety, Commercial, and Marketing.
Interpret and contextualize findings generated by the REMS Advisor team.
Conduct analyses using clinical and real-world data to support strategic and operational decisions.
Monitor industry developments and assess their impact on REMS programs and reporting requirements.
Stakeholder Management
Develop a strong understanding of prescriber and pharmacy operational environments.
Collaborate with vendors, consultants, and internal stakeholders to improve reporting capabilities.
Analyze stakeholder feedback and complaints, identify root causes, and recommend practical solutions.
Support leadership with scheduled and on-demand reporting requirements.
Compliance and Audit Support
Support audit activities related to BMS REMS and Clinical programs.
Ensure adherence to data governance, validation processes, and documentation standards.
Maintain confidentiality and integrity of sensitive business and patient-related information.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Statistics, Data Analytics, Computer Science, Public Health, or a related field.
Master's degree or advanced qualification preferred.
5–8 years of relevant experience in the pharmaceutical, biotechnology, clinical research, or healthcare industry.
Understanding of FDA Risk Evaluation and Mitigation Strategies (REMS) regulations and compliance requirements.
Experience in analytical reporting and healthcare data analytics.
Required Technical Skills
Advanced proficiency in Microsoft Excel and PowerPoint.
Strong knowledge of Tableau and familiarity with Spotfire.
Experience with programming languages such as SAS, SQL, Python, or similar analytical tools.
Experience working with databases including Salesforce, PostgreSQL, Oracle, SharePoint Lists, or equivalent systems.
Knowledge of data visualization, reporting automation, and business intelligence tools.
Understanding of validation processes and associated documentation.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Remote, India | Siliguri |Illinois :
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China | Quarry Bay |Liaoning :
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Croatia |Zagreb :
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Tartu | Estonia |Harju County (Maakond) :
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Japan | Saitama |Tokyo :
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