Manager, Clinical And Safety Analytics

Bristol Myers Squibb

2+ years

Not Disclosed

Hyderabad

10 Aug. 14, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Position Summary:

Join Bristol Myers Squibb, where your work will be anything but ordinary. As a pivotal member of our Worldwide Patient Safety & Pharmacovigilance Center of Excellence (PV CoE) Analytics team, you will develop and enhance a data analytics framework that drives decision-making and compliance within our REMS (Risk Evaluation and Mitigation Strategies) programs. This role involves utilizing data analytics tools, maintaining reporting and visualization applications, and ensuring regulatory compliance through cross-functional collaboration. Your insights will help optimize productivity, efficiency, and quality across the organization.

Key Responsibilities:

Regulatory Compliance & Safety: Ensure adherence to regulatory requirements and enhance drug safety through qualitative and quantitative research, collaborating with cross-functional teams including Regulatory, Medical & Clinical Safety, and Commercial.
Data Management & Reporting: Develop, maintain, and optimize reporting and analytics applications using tools like Tableau and Excel. Efficiently manage data visualization and reporting processes to minimize manual efforts.
Data Analysis & Insights: Aggregate and analyze data to provide actionable recommendations. Develop and present reports on key activities, outcomes, and trends to management regularly.
Industry Awareness: Stay informed on the evolving healthcare landscape and its impact on REMS programs. Engage with stakeholders, vendors, and industry events to gain a deep understanding of the prescriber and pharmacy environments.
Stakeholder Engagement: Analyze and address key stakeholder concerns, collaborating with functional leads to propose impactful solutions.
Training & Change Management: Partner with WWPS members to develop change management strategies, support stakeholder analysis, and execute end-user training programs. Evaluate instructional approaches and ensure readiness for system changes.

Other Responsibilities:

Provide scheduled and ad-hoc reports to leadership as required.
Support audit activities related to BMS REMS programs.

Required Qualifications:

Education: BS/BA degree required; a Master’s or advanced degree is preferred. Understanding of FDA REMS regulations with 4-8 years of relevant pharma/biotech experience.
Technical Skills: Proficiency in PowerPoint, Excel, and programming languages like SAS, SQL, or Python. Strong knowledge of Tableau and databases such as Salesforce, Postgres, Oracle, and SharePoint.
Analytical Skills: Ability to curate data, identify patterns, and provide strategic insights. Knowledge of validation processes and associated documentation.
Communication: Excellent verbal, writing, and presentation skills. Strong project management abilities and strategic orientation.
Collaboration: Ability to work on multiple projects, prioritize tasks, and balance competing priorities. Flexibility and a positive attitude are essential.
Integrity: Confidentiality and a strong work ethic are a must.

Why Bristol Myers Squibb?

At BMS, every employee contributes to our mission of transforming patients’ lives through science. We foster a diverse and inclusive culture, empowering our teams to apply their unique talents and perspectives. Our shared values—passion, innovation, urgency, accountability, inclusion, and integrity—guide our work and ensure we achieve our highest potential.

Work Environment:

BMS offers a flexible work environment tailored to the needs of each role. Depending on the nature of your responsibilities, you may be required to work onsite, in a hybrid model, or remotely. We support our employees with reasonable workplace accommodations and encourage all staff to be fully vaccinated for Covid-19.

Equal Opportunity Employment:

BMS is committed to providing equal employment opportunities for all applicants, including those with arrest and conviction records, in accordance with applicable laws. We ensure that all data processed during role applications is handled in compliance with relevant data privacy regulations.

For more information about working at BMS, visit careers.bms.com/working-with-us.

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Manager, Clinical And Safety Analytics

Job Description

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