Associate Director, Patient Safety Scientist at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Strong capability in using a wide range of tools/data sources to assess safety concerns
Demonstrates sound judgment and strategic awareness in escalating issues
Ability to lead SDRMs by reviewing and evaluating clinical data
Expertise in driving strategy and execution for signal evaluation (e.g., case-series, literature review, health authority/claims databases)
Strong medical writing skills for safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER)
Experience executing strategy, analyzing data, and writing ad hoc responses to health authorities
Ability to mentor less experienced scientists
Capability to lead preparation, review, and strategic input for safety sections in clinical trial documents (e.g., protocols, CSR, IB, ICF)
Experience representing Patient Safety at internal and external meetings
Expertise in executing safety strategy for regulatory filings (e.g., MAA safety sections, ISS, SCS)
Ability to author responses to ad hoc regulatory safety requests and support labeling updates
Knowledge to support EU QPPV or regional/local QP for safety issues
Responsibility for creation and update of the EDSR

Responsibilities

Drives core signal detection and assessment activities throughout product life cycle, including review of safety-related literature and quantitative signal detection, in partnership with the SMT Chair
Leads SDRMs by reviewing and evaluating clinical data to support signal detection and escalates issues to SMT Chair
Drives strategy and execution for signal evaluation, promotes cross-functional collaboration, authors signal reports, and ensures timely tracking and documentation
Executes strategy and provides medical writing for safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER)
Executes strategy, analyzes data, writes ad hoc responses to health authorities, and mentors less experienced scientists
Leads preparation, review, and strategic input for safety sections in key clinical trial documents (e.g., protocols, CSR, IB including RSI, ICF, contraception language)
Represents Patient Safety and supports safety strategy at internal and external meetings (e.g., pre-submission, Advisory Committees, Scientific Advice, data monitoring committees, publications)
Executes safety strategy for regulatory filings, contributes to key safety messages and risk management, reviews/authors safety sections of MAA (e.g., ISS, SCS, clinical overview, briefing book, labeling)
Authors responses to ad hoc regulatory safety requests (e.g., 120-day safety updates) and proactively sources/interprets safety data for benefit-risk profile
Provides input into strategy, analyzes data, and authors documentation for safety labeling updates
Supports EU QPPV or other regional/local QP for safety issues on assigned products
Responsible for creation and update of the EDSR to proactively characterize emerging safety concerns during asset development

Skills

Key technologies and capabilities for this role

Signal DetectionSafety SurveillanceRisk ManagementClinical Data ReviewSignal EvaluationCase-Series AnalysisLiterature ReviewHealth Authority DatabasesClaims DatabasesSignal ReportsCross-Functional CollaborationStrategic Decision-Making

Questions & Answers

Common questions about this position

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What salary can I expect for the Associate Director, Patient Safety Scientist role?

This information is not specified in the job description.

What key skills are required for this Patient Safety Scientist position?

The role requires strong capabilities in signal detection and assessment using various tools and data sources, leading safety data review meetings (SDRMs), strategic signal evaluation including case-series and literature reviews, and medical writing for safety sections in aggregate documents and regulatory responses.

What is the company culture like at Bristol Myers Squibb?

The culture is challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow and thrive alongside high-achieving teams, and a focus on balance and flexibility.

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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