Associate Director, Patient Safety Scientist
Bristol-Myers Squibb
Associate Director, Patient Safety Scientist
Job Description
Executes on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches. Provides input into strategy, analyzes data, and authors documentation as needed to support safety labeling updates to adequately reflect emerging postmarketing safety profile. Supports the 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, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gaining alignment with SMT/governance, including collaboration with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS). Provides strategic leadership and is accountable for the development and maintenance of global and EU Risk Management Plans (RMPs), including understanding of in-licensing arrangements or pharmacovigilance agreements that may impact risk management activities. Provides guidance to local markets and vendors for complex (eg, Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e.g., educational materials). Leverages automation and innovation tools into day-to-day work, with an understanding of current processes and ability to evaluate and suggest digital improvements. Uses multiple data sources and AI generated outputs to support decisions. Supports preparation for regulatory inspections and audits with evaluation of current processes and assesses alignment with regulatory expectations, guidelines, and mandates. Cultivates effective collaboration by engaging regularly with all TA staff, serving as a role model in cross-functional interactions, and contributing to a culture of excellence, accountability, and continuous improvement. Leads or identifies opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update and maintenance of procedural documents. Builds cross-functional partnerships with SMT/ACT stakeholders, exercising matrix leadership to drive alignment, accountability, and timely decision-making across functions. Possesses deep knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations and industry trends; shares with cross-functional teams as needed. Supporting People with Disabilities Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience Minimum of 6-8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor others Co-develops and executes safety strategies across programs by synthesizing complex data (clinical, nonclinical, postmarketing, literature) to inform decisions and influence stakeholders, leveraging deep understanding of medical concepts and safety activities. Effectively manages team priorities, timelines, and quality through strong communication, collaboration, and organizational skills, proactively escalating risks to timelines or deliverables. Consistently demonstrates initiative and professionalism to operate both independently and as a team player to resolve program-level challenges in dynamic, fast-paced environments. Makes sound decisions by integrating scientific knowledge, analytical thinking, experience, and judgment; applies exceptional attention to detail, conceptual thinking, and scientific training to interpret complex medical data across disciplines and drive strategic insights. Solid understanding of data analysis, interpretation, and presentation, including foundational statistical methods, with growing ability to integrate emerging technologies (AI, automation, digital platforms) to optimize workflows, enhance data analysis, and uphold scientific rigor and compliance.
Key Responsibilities
- Execute on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches
- Provide input into strategy, analyze data, and author documentation to support safety labeling updates reflecting emerging postmarketing safety profile
- Support the EU QPPV or other regional/local QP for safety issues on assigned products
- Create and update the EDSR to characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define strategy for Company Core Risk Management
- Gain alignment with SMT/governance on risk management, including collaboration with Epidemiology on risk minimization effectiveness and non-interventional research (NIR) activities for post-authorization safety studies (PASS)
- Provide strategic leadership and be accountable for the development and maintenance of global and EU Risk Management Plans (RMPs)
- Understand in-licensing arrangements or pharmacovigilance agreements impacting risk management activities
- Guide local markets and vendors for complex and non-complex aRMMs (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs, educational materials)
- Leverage automation and innovation tools into day-to-day work, evaluate and suggest digital improvements
- Use multiple data sources and AI generated outputs to support decisions
- Support preparation for regulatory inspections and audits, evaluate current processes, and assess alignment with regulatory expectations, guidelines, and mandates
- Cultivate effective collaboration by engaging regularly with all TA staff, serve as a role model in cross-functional interactions, and contribute to a culture of excellence, accountability, and continuous improvement
- Lead or identify opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update and maintenance of procedural documents
- Build cross-functional partnerships with SMT/ACT stakeholders, exercise matrix leadership to drive alignment, accountability, and timely decision-making across functions
- Possess deep knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations and industry trends; share with cross-functional teams as needed
- Co-develop and execute safety strategies across programs by synthesizing complex data (clinical, nonclinical, postmarketing, literature) to inform decisions and influence stakeholders
- Effectively manage team priorities, timelines, and quality through strong communication, collaboration, and organizational skills, proactively escalate risks to timelines or deliverables
- Demonstrate initiative and professionalism to operate both independently and as a team player to resolve program-level challenges in dynamic, fast-paced environments
- Make sound decisions by integrating scientific knowledge, analytical thinking, experience, and judgment; apply exceptional attention to detail, conceptual thinking, and scientific training to interpret complex medical data across disciplines and drive strategic insights
Required Qualifications
- Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or equivalent combination of relevant education and professional experience
- Minimum of 6-8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience
Skills Required
- Ability to mentor others
- Deep understanding of medical concepts and safety activities
- Strong communication, collaboration, and organizational skills
- Proactive risk escalation
- Initiative and professionalism
- Ability to operate independently and as a team player
- Integration of scientific knowledge, analytical thinking, experience, and judgment
- Exceptional attention to detail, conceptual thinking, and scientific training
- Solid understanding of data analysis, interpretation, and presentation, including foundational statistical methods
- Growing ability to integrate emerging technologies (AI, automation, digital platforms) to optimize workflows, enhance data analysis, and uphold scientific rigor and compliance
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
1,500,000 - 2,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to mentor othersintermediate
- Deep understanding of medical concepts and safety activitiesintermediate
- Strong communication, collaboration, and organizational skillsintermediate
- Proactive risk escalationintermediate
- Initiative and professionalismintermediate
- Ability to operate independently and as a team playerintermediate
- Integration of scientific knowledge, analytical thinking, experience, and judgmentintermediate
- Exceptional attention to detail, conceptual thinking, and scientific trainingintermediate
- Solid understanding of data analysis, interpretation, and presentation, including foundational statistical methodsintermediate
- Growing ability to integrate emerging technologies (AI, automation, digital platforms) to optimize workflows, enhance data analysis, and uphold scientific rigor and complianceintermediate
Required Qualifications
- Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or equivalent combination of relevant education and professional experience (experience)
- Minimum of 6-8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience (experience)
Responsibilities
- Execute on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches
- Provide input into strategy, analyze data, and author documentation to support safety labeling updates reflecting emerging postmarketing safety profile
- Support the EU QPPV or other regional/local QP for safety issues on assigned products
- Create and update the EDSR to characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define strategy for Company Core Risk Management
- Gain alignment with SMT/governance on risk management, including collaboration with Epidemiology on risk minimization effectiveness and non-interventional research (NIR) activities for post-authorization safety studies (PASS)
- Provide strategic leadership and be accountable for the development and maintenance of global and EU Risk Management Plans (RMPs)
- Understand in-licensing arrangements or pharmacovigilance agreements impacting risk management activities
- Guide local markets and vendors for complex and non-complex aRMMs (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs, educational materials)
- Leverage automation and innovation tools into day-to-day work, evaluate and suggest digital improvements
- Use multiple data sources and AI generated outputs to support decisions
- Support preparation for regulatory inspections and audits, evaluate current processes, and assess alignment with regulatory expectations, guidelines, and mandates
- Cultivate effective collaboration by engaging regularly with all TA staff, serve as a role model in cross-functional interactions, and contribute to a culture of excellence, accountability, and continuous improvement
- Lead or identify opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update and maintenance of procedural documents
- Build cross-functional partnerships with SMT/ACT stakeholders, exercise matrix leadership to drive alignment, accountability, and timely decision-making across functions
- Possess deep knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations and industry trends; share with cross-functional teams as needed
- Co-develop and execute safety strategies across programs by synthesizing complex data (clinical, nonclinical, postmarketing, literature) to inform decisions and influence stakeholders
- Effectively manage team priorities, timelines, and quality through strong communication, collaboration, and organizational skills, proactively escalate risks to timelines or deliverables
- Demonstrate initiative and professionalism to operate both independently and as a team player to resolve program-level challenges in dynamic, fast-paced environments
- Make sound decisions by integrating scientific knowledge, analytical thinking, experience, and judgment; apply exceptional attention to detail, conceptual thinking, and scientific training to interpret complex medical data across disciplines and drive strategic insights
Tags & Categories
Associate Director, Patient Safety Scientist
Bristol-Myers Squibb
Associate Director, Patient Safety Scientist
Job Description
Executes on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches. Provides input into strategy, analyzes data, and authors documentation as needed to support safety labeling updates to adequately reflect emerging postmarketing safety profile. Supports the 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, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gaining alignment with SMT/governance, including collaboration with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS). Provides strategic leadership and is accountable for the development and maintenance of global and EU Risk Management Plans (RMPs), including understanding of in-licensing arrangements or pharmacovigilance agreements that may impact risk management activities. Provides guidance to local markets and vendors for complex (eg, Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e.g., educational materials). Leverages automation and innovation tools into day-to-day work, with an understanding of current processes and ability to evaluate and suggest digital improvements. Uses multiple data sources and AI generated outputs to support decisions. Supports preparation for regulatory inspections and audits with evaluation of current processes and assesses alignment with regulatory expectations, guidelines, and mandates. Cultivates effective collaboration by engaging regularly with all TA staff, serving as a role model in cross-functional interactions, and contributing to a culture of excellence, accountability, and continuous improvement. Leads or identifies opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update and maintenance of procedural documents. Builds cross-functional partnerships with SMT/ACT stakeholders, exercising matrix leadership to drive alignment, accountability, and timely decision-making across functions. Possesses deep knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations and industry trends; shares with cross-functional teams as needed. Supporting People with Disabilities Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience Minimum of 6-8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor others Co-develops and executes safety strategies across programs by synthesizing complex data (clinical, nonclinical, postmarketing, literature) to inform decisions and influence stakeholders, leveraging deep understanding of medical concepts and safety activities. Effectively manages team priorities, timelines, and quality through strong communication, collaboration, and organizational skills, proactively escalating risks to timelines or deliverables. Consistently demonstrates initiative and professionalism to operate both independently and as a team player to resolve program-level challenges in dynamic, fast-paced environments. Makes sound decisions by integrating scientific knowledge, analytical thinking, experience, and judgment; applies exceptional attention to detail, conceptual thinking, and scientific training to interpret complex medical data across disciplines and drive strategic insights. Solid understanding of data analysis, interpretation, and presentation, including foundational statistical methods, with growing ability to integrate emerging technologies (AI, automation, digital platforms) to optimize workflows, enhance data analysis, and uphold scientific rigor and compliance.
Key Responsibilities
- Execute on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches
- Provide input into strategy, analyze data, and author documentation to support safety labeling updates reflecting emerging postmarketing safety profile
- Support the EU QPPV or other regional/local QP for safety issues on assigned products
- Create and update the EDSR to characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define strategy for Company Core Risk Management
- Gain alignment with SMT/governance on risk management, including collaboration with Epidemiology on risk minimization effectiveness and non-interventional research (NIR) activities for post-authorization safety studies (PASS)
- Provide strategic leadership and be accountable for the development and maintenance of global and EU Risk Management Plans (RMPs)
- Understand in-licensing arrangements or pharmacovigilance agreements impacting risk management activities
- Guide local markets and vendors for complex and non-complex aRMMs (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs, educational materials)
- Leverage automation and innovation tools into day-to-day work, evaluate and suggest digital improvements
- Use multiple data sources and AI generated outputs to support decisions
- Support preparation for regulatory inspections and audits, evaluate current processes, and assess alignment with regulatory expectations, guidelines, and mandates
- Cultivate effective collaboration by engaging regularly with all TA staff, serve as a role model in cross-functional interactions, and contribute to a culture of excellence, accountability, and continuous improvement
- Lead or identify opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update and maintenance of procedural documents
- Build cross-functional partnerships with SMT/ACT stakeholders, exercise matrix leadership to drive alignment, accountability, and timely decision-making across functions
- Possess deep knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations and industry trends; share with cross-functional teams as needed
- Co-develop and execute safety strategies across programs by synthesizing complex data (clinical, nonclinical, postmarketing, literature) to inform decisions and influence stakeholders
- Effectively manage team priorities, timelines, and quality through strong communication, collaboration, and organizational skills, proactively escalate risks to timelines or deliverables
- Demonstrate initiative and professionalism to operate both independently and as a team player to resolve program-level challenges in dynamic, fast-paced environments
- Make sound decisions by integrating scientific knowledge, analytical thinking, experience, and judgment; apply exceptional attention to detail, conceptual thinking, and scientific training to interpret complex medical data across disciplines and drive strategic insights
Required Qualifications
- Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or equivalent combination of relevant education and professional experience
- Minimum of 6-8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience
Skills Required
- Ability to mentor others
- Deep understanding of medical concepts and safety activities
- Strong communication, collaboration, and organizational skills
- Proactive risk escalation
- Initiative and professionalism
- Ability to operate independently and as a team player
- Integration of scientific knowledge, analytical thinking, experience, and judgment
- Exceptional attention to detail, conceptual thinking, and scientific training
- Solid understanding of data analysis, interpretation, and presentation, including foundational statistical methods
- Growing ability to integrate emerging technologies (AI, automation, digital platforms) to optimize workflows, enhance data analysis, and uphold scientific rigor and compliance
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
1,500,000 - 2,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to mentor othersintermediate
- Deep understanding of medical concepts and safety activitiesintermediate
- Strong communication, collaboration, and organizational skillsintermediate
- Proactive risk escalationintermediate
- Initiative and professionalismintermediate
- Ability to operate independently and as a team playerintermediate
- Integration of scientific knowledge, analytical thinking, experience, and judgmentintermediate
- Exceptional attention to detail, conceptual thinking, and scientific trainingintermediate
- Solid understanding of data analysis, interpretation, and presentation, including foundational statistical methodsintermediate
- Growing ability to integrate emerging technologies (AI, automation, digital platforms) to optimize workflows, enhance data analysis, and uphold scientific rigor and complianceintermediate
Required Qualifications
- Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or equivalent combination of relevant education and professional experience (experience)
- Minimum of 6-8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience (experience)
Responsibilities
- Execute on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches
- Provide input into strategy, analyze data, and author documentation to support safety labeling updates reflecting emerging postmarketing safety profile
- Support the EU QPPV or other regional/local QP for safety issues on assigned products
- Create and update the EDSR to characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define strategy for Company Core Risk Management
- Gain alignment with SMT/governance on risk management, including collaboration with Epidemiology on risk minimization effectiveness and non-interventional research (NIR) activities for post-authorization safety studies (PASS)
- Provide strategic leadership and be accountable for the development and maintenance of global and EU Risk Management Plans (RMPs)
- Understand in-licensing arrangements or pharmacovigilance agreements impacting risk management activities
- Guide local markets and vendors for complex and non-complex aRMMs (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs, educational materials)
- Leverage automation and innovation tools into day-to-day work, evaluate and suggest digital improvements
- Use multiple data sources and AI generated outputs to support decisions
- Support preparation for regulatory inspections and audits, evaluate current processes, and assess alignment with regulatory expectations, guidelines, and mandates
- Cultivate effective collaboration by engaging regularly with all TA staff, serve as a role model in cross-functional interactions, and contribute to a culture of excellence, accountability, and continuous improvement
- Lead or identify opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update and maintenance of procedural documents
- Build cross-functional partnerships with SMT/ACT stakeholders, exercise matrix leadership to drive alignment, accountability, and timely decision-making across functions
- Possess deep knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations and industry trends; share with cross-functional teams as needed
- Co-develop and execute safety strategies across programs by synthesizing complex data (clinical, nonclinical, postmarketing, literature) to inform decisions and influence stakeholders
- Effectively manage team priorities, timelines, and quality through strong communication, collaboration, and organizational skills, proactively escalate risks to timelines or deliverables
- Demonstrate initiative and professionalism to operate both independently and as a team player to resolve program-level challenges in dynamic, fast-paced environments
- Make sound decisions by integrating scientific knowledge, analytical thinking, experience, and judgment; apply exceptional attention to detail, conceptual thinking, and scientific training to interpret complex medical data across disciplines and drive strategic insights
Tags & Categories