Senior Manager, Patient Safety Scientist
Bristol-Myers Squibb
Senior Manager, Patient Safety Scientist
Job Description
Contributes to the preparation/review of safety sections in clinical trial documents, such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language, with oversight. Executes on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches. Contributes to ad hoc regulatory safety requests (e.g., 120-day safety response updates) and obtains safety data to determine the impact of the safety issue on the product's benefit/risk profile. Analyzes data and authors documentation as needed to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile. Supports the EU QPPV or other regional/local QP for safety issues on assigned products. Responsible for the 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). Develops and maintains global and EU local Risk Management Plans (RMPs) and understands in-licensing or pharmacovigilance agreements that may impact risk management activities. Develops and maintains core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally. Coordinates with local markets and vendors for complex (e.g., 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. Participates in team activities by engaging with TA staff and contributing to a collaborative working environment through consistent communication and professional conduct. Collaborates on and identifies opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update/maintenance of procedural documents. Builds cross-functional partnerships with SMT and ACT membership and stakeholders. Maintains solid knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations; shares with cross-functional teams as needed. 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 4-6 years of relevant pharmacovigilance/pharmaceutical industry/drug development experience Working understanding of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirements. Working understanding of team priorities and milestones. Ability to manage timelines and quality of work through communication, cross-functional collaboration, and organizational skills, appropriately communicating items that could impact timelines or quality. Adaptable / flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism. Applies attention to detail along with strong scientific, analytical, and conceptual skills and scientific training to understand complex medical-scientific data across disciplines (e.g., clinical and nonclinical data, postmarketing reports, scientific literature, and regulatory documents). Understands aspects and methods for data analysis, interpretation, and presentation, including an understanding of basic statistics, with basic ability to begin applying emerging technologies (AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort to ensure compliance with safety standards. Supporting People with Disabilities
Key Responsibilities
- Contribute to the preparation/review of safety sections in clinical trial documents such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language, with oversight
- Execute on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches
- Contribute to ad hoc regulatory safety requests (e.g., 120-day safety response updates) and obtain safety data to determine the impact of the safety issue on the product's benefit/risk profile
- Analyze data and author documentation to support safety labeling updates to ensure labeling adequately reflects the 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 proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gain alignment with SMT/governance
- Collaborate with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS)
- Develop and maintain global and EU local Risk Management Plans (RMPs) and understand in-licensing or pharmacovigilance agreements that may impact risk management activities
- Develop and maintain core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally
- Coordinate with local markets and vendors for complex (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e.g., educational materials)
- Leverage automation and innovation tools into day-to-day work, with an understanding of current processes and ability to evaluate and suggest digital improvements
- Use multiple data sources and AI generated outputs to support decisions
- Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates
- Participate in team activities by engaging with TA staff and contributing to a collaborative working environment through consistent communication and professional conduct
- Collaborate on and identify opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update/maintenance of procedural documents
- Build cross-functional partnerships with SMT and ACT membership and stakeholders
- Maintain solid knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations; share with cross-functional teams as needed
Required Qualifications
- Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or equivalent combination of relevant education and professional experience
- Minimum of 4-6 years of relevant pharmacovigilance/pharmaceutical industry/drug development experience
Skills Required
- Working understanding of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirements
- Working understanding of team priorities and milestones
- Ability to manage timelines and quality of work through communication, cross-functional collaboration, and organizational skills, appropriately communicating items that could impact timelines or quality
- Adaptable/flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
- Attention to detail along with strong scientific, analytical, and conceptual skills and scientific training to understand complex medical-scientific data across disciplines (e.g., clinical and nonclinical data, postmarketing reports, scientific literature, and regulatory documents)
- Understanding of aspects and methods for data analysis, interpretation, and presentation, including an understanding of basic statistics
- Basic ability to begin applying emerging technologies (AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort to ensure compliance with safety standards
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
2,500,000 - 4,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Working understanding of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirementsintermediate
- Working understanding of team priorities and milestonesintermediate
- Ability to manage timelines and quality of work through communication, cross-functional collaboration, and organizational skills, appropriately communicating items that could impact timelines or qualityintermediate
- Adaptable/flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalismintermediate
- Attention to detail along with strong scientific, analytical, and conceptual skills and scientific training to understand complex medical-scientific data across disciplines (e.g., clinical and nonclinical data, postmarketing reports, scientific literature, and regulatory documents)intermediate
- Understanding of aspects and methods for data analysis, interpretation, and presentation, including an understanding of basic statisticsintermediate
- Basic ability to begin applying emerging technologies (AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort to ensure compliance with safety standardsintermediate
Required Qualifications
- Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or equivalent combination of relevant education and professional experience (experience)
- Minimum of 4-6 years of relevant pharmacovigilance/pharmaceutical industry/drug development experience (experience)
Responsibilities
- Contribute to the preparation/review of safety sections in clinical trial documents such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language, with oversight
- Execute on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches
- Contribute to ad hoc regulatory safety requests (e.g., 120-day safety response updates) and obtain safety data to determine the impact of the safety issue on the product's benefit/risk profile
- Analyze data and author documentation to support safety labeling updates to ensure labeling adequately reflects the 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 proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gain alignment with SMT/governance
- Collaborate with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS)
- Develop and maintain global and EU local Risk Management Plans (RMPs) and understand in-licensing or pharmacovigilance agreements that may impact risk management activities
- Develop and maintain core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally
- Coordinate with local markets and vendors for complex (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e.g., educational materials)
- Leverage automation and innovation tools into day-to-day work, with an understanding of current processes and ability to evaluate and suggest digital improvements
- Use multiple data sources and AI generated outputs to support decisions
- Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates
- Participate in team activities by engaging with TA staff and contributing to a collaborative working environment through consistent communication and professional conduct
- Collaborate on and identify opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update/maintenance of procedural documents
- Build cross-functional partnerships with SMT and ACT membership and stakeholders
- Maintain solid knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations; share with cross-functional teams as needed
Tags & Categories
Senior Manager, Patient Safety Scientist
Bristol-Myers Squibb
Senior Manager, Patient Safety Scientist
Job Description
Contributes to the preparation/review of safety sections in clinical trial documents, such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language, with oversight. Executes on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches. Contributes to ad hoc regulatory safety requests (e.g., 120-day safety response updates) and obtains safety data to determine the impact of the safety issue on the product's benefit/risk profile. Analyzes data and authors documentation as needed to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile. Supports the EU QPPV or other regional/local QP for safety issues on assigned products. Responsible for the 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). Develops and maintains global and EU local Risk Management Plans (RMPs) and understands in-licensing or pharmacovigilance agreements that may impact risk management activities. Develops and maintains core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally. Coordinates with local markets and vendors for complex (e.g., 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. Participates in team activities by engaging with TA staff and contributing to a collaborative working environment through consistent communication and professional conduct. Collaborates on and identifies opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update/maintenance of procedural documents. Builds cross-functional partnerships with SMT and ACT membership and stakeholders. Maintains solid knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations; shares with cross-functional teams as needed. 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 4-6 years of relevant pharmacovigilance/pharmaceutical industry/drug development experience Working understanding of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirements. Working understanding of team priorities and milestones. Ability to manage timelines and quality of work through communication, cross-functional collaboration, and organizational skills, appropriately communicating items that could impact timelines or quality. Adaptable / flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism. Applies attention to detail along with strong scientific, analytical, and conceptual skills and scientific training to understand complex medical-scientific data across disciplines (e.g., clinical and nonclinical data, postmarketing reports, scientific literature, and regulatory documents). Understands aspects and methods for data analysis, interpretation, and presentation, including an understanding of basic statistics, with basic ability to begin applying emerging technologies (AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort to ensure compliance with safety standards. Supporting People with Disabilities
Key Responsibilities
- Contribute to the preparation/review of safety sections in clinical trial documents such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language, with oversight
- Execute on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches
- Contribute to ad hoc regulatory safety requests (e.g., 120-day safety response updates) and obtain safety data to determine the impact of the safety issue on the product's benefit/risk profile
- Analyze data and author documentation to support safety labeling updates to ensure labeling adequately reflects the 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 proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gain alignment with SMT/governance
- Collaborate with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS)
- Develop and maintain global and EU local Risk Management Plans (RMPs) and understand in-licensing or pharmacovigilance agreements that may impact risk management activities
- Develop and maintain core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally
- Coordinate with local markets and vendors for complex (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e.g., educational materials)
- Leverage automation and innovation tools into day-to-day work, with an understanding of current processes and ability to evaluate and suggest digital improvements
- Use multiple data sources and AI generated outputs to support decisions
- Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates
- Participate in team activities by engaging with TA staff and contributing to a collaborative working environment through consistent communication and professional conduct
- Collaborate on and identify opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update/maintenance of procedural documents
- Build cross-functional partnerships with SMT and ACT membership and stakeholders
- Maintain solid knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations; share with cross-functional teams as needed
Required Qualifications
- Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or equivalent combination of relevant education and professional experience
- Minimum of 4-6 years of relevant pharmacovigilance/pharmaceutical industry/drug development experience
Skills Required
- Working understanding of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirements
- Working understanding of team priorities and milestones
- Ability to manage timelines and quality of work through communication, cross-functional collaboration, and organizational skills, appropriately communicating items that could impact timelines or quality
- Adaptable/flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
- Attention to detail along with strong scientific, analytical, and conceptual skills and scientific training to understand complex medical-scientific data across disciplines (e.g., clinical and nonclinical data, postmarketing reports, scientific literature, and regulatory documents)
- Understanding of aspects and methods for data analysis, interpretation, and presentation, including an understanding of basic statistics
- Basic ability to begin applying emerging technologies (AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort to ensure compliance with safety standards
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
2,500,000 - 4,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Working understanding of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirementsintermediate
- Working understanding of team priorities and milestonesintermediate
- Ability to manage timelines and quality of work through communication, cross-functional collaboration, and organizational skills, appropriately communicating items that could impact timelines or qualityintermediate
- Adaptable/flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalismintermediate
- Attention to detail along with strong scientific, analytical, and conceptual skills and scientific training to understand complex medical-scientific data across disciplines (e.g., clinical and nonclinical data, postmarketing reports, scientific literature, and regulatory documents)intermediate
- Understanding of aspects and methods for data analysis, interpretation, and presentation, including an understanding of basic statisticsintermediate
- Basic ability to begin applying emerging technologies (AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort to ensure compliance with safety standardsintermediate
Required Qualifications
- Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or equivalent combination of relevant education and professional experience (experience)
- Minimum of 4-6 years of relevant pharmacovigilance/pharmaceutical industry/drug development experience (experience)
Responsibilities
- Contribute to the preparation/review of safety sections in clinical trial documents such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language, with oversight
- Execute on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches
- Contribute to ad hoc regulatory safety requests (e.g., 120-day safety response updates) and obtain safety data to determine the impact of the safety issue on the product's benefit/risk profile
- Analyze data and author documentation to support safety labeling updates to ensure labeling adequately reflects the 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 proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gain alignment with SMT/governance
- Collaborate with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS)
- Develop and maintain global and EU local Risk Management Plans (RMPs) and understand in-licensing or pharmacovigilance agreements that may impact risk management activities
- Develop and maintain core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally
- Coordinate with local markets and vendors for complex (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e.g., educational materials)
- Leverage automation and innovation tools into day-to-day work, with an understanding of current processes and ability to evaluate and suggest digital improvements
- Use multiple data sources and AI generated outputs to support decisions
- Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates
- Participate in team activities by engaging with TA staff and contributing to a collaborative working environment through consistent communication and professional conduct
- Collaborate on and identify opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update/maintenance of procedural documents
- Build cross-functional partnerships with SMT and ACT membership and stakeholders
- Maintain solid knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations; share with cross-functional teams as needed
Tags & Categories