Senior Manager, Pharmacovigilance Scientist - Bristol Myers Squibb
Madison, NJ
About the Job
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Position Summary
Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key Safety Managment Team (SMT) programs, priorities, resources, and milestones with appropriate oversight. Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensure pharmacovigilance regulatory compliance with oversight, as needed.
Position Responsibilities:
General Product Support
• Supports Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product's emerging safety profile.
• Prepare/write PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyze data for the RSI section of the IB. Write and analyze data for ad hoc responses to health authorities, with oversight.
• Execute strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document signal by Safety Topic Review/ Signal Report.
• Analyze data and prepare documentation to support label updates for assigned products, with oversight.
• Support Safety input for regulatory product labeling.
• Support the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products.
• Working knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.
Clinical Development & Post Marketing Product Support
• Perform core surveillance activities, signal assessment according to the product stage of development for a multiple coumponds, with oversight, as needed.
• Lead Safety Data Review Meetings (SDRM) in the review and evaluation of clinical data to support signal detection. Appropriately elevate issues impacting key SMT activities, milestones, and documents to the SMT Chair with oversight, as needed.
• Contributes to specified PV sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with oversight, as needed.
• Perform periodic review and summary of pertinent safety- related literature and analysis of pre-determined core signal data.
• Executes the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Partner with SMT Chair on the evaluation & management of signals emerging from any data source. Authors the Safety Topic Review/ Signal Report
and tracks signals for other means of communication, with
oversight, as needed.
• Perform the review and evaluation of SARs for inclusion in the IB RSI, including presentation to SMT to ensure alignment. Author the IB RSI table, for less complex products with oversight, as needed.
• Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, with oversight as needed.
Department Activities
• Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
• Support hiring & orientation.
Cross Functional Activities
• Support process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.
• Builds cross functional relationships with SMT membership and stakeholders
Leadership Behaviors
• Learner
• Seeks feedback and best practices for continued development
Degree Requirements
Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience.
Experience Requirements
3 - 5 years relevant Pharmacovigilance/Pharmaceutical Industry experience.
Key Competency Requirements
• Working understanding of medical concepts and some 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 using organizational and interpersonal communication skills. Appropriately communicates 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)
• Ability to work well in cross-functional teams.
• Good collaborative and communication skills with scientific subject
matter.
• Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data,
postmarketing reports, scientific literature, and regulatory documents).
• Understand aspects and methods for data analysis, interpretation and
presentation.
• Possess good working skills in MS Word, Excel and PowerPoint,
including statistics
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1583128
Updated: 2024-07-05 03:04:38.178 UTC
Location: Madison-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Position Summary
Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key Safety Managment Team (SMT) programs, priorities, resources, and milestones with appropriate oversight. Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensure pharmacovigilance regulatory compliance with oversight, as needed.
Position Responsibilities:
General Product Support
• Supports Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product's emerging safety profile.
• Prepare/write PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyze data for the RSI section of the IB. Write and analyze data for ad hoc responses to health authorities, with oversight.
• Execute strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document signal by Safety Topic Review/ Signal Report.
• Analyze data and prepare documentation to support label updates for assigned products, with oversight.
• Support Safety input for regulatory product labeling.
• Support the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products.
• Working knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.
Clinical Development & Post Marketing Product Support
• Perform core surveillance activities, signal assessment according to the product stage of development for a multiple coumponds, with oversight, as needed.
• Lead Safety Data Review Meetings (SDRM) in the review and evaluation of clinical data to support signal detection. Appropriately elevate issues impacting key SMT activities, milestones, and documents to the SMT Chair with oversight, as needed.
• Contributes to specified PV sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with oversight, as needed.
• Perform periodic review and summary of pertinent safety- related literature and analysis of pre-determined core signal data.
• Executes the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Partner with SMT Chair on the evaluation & management of signals emerging from any data source. Authors the Safety Topic Review/ Signal Report
and tracks signals for other means of communication, with
oversight, as needed.
• Perform the review and evaluation of SARs for inclusion in the IB RSI, including presentation to SMT to ensure alignment. Author the IB RSI table, for less complex products with oversight, as needed.
• Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, with oversight as needed.
Department Activities
• Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
• Support hiring & orientation.
Cross Functional Activities
• Support process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.
• Builds cross functional relationships with SMT membership and stakeholders
Leadership Behaviors
• Learner
• Seeks feedback and best practices for continued development
Degree Requirements
Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience.
Experience Requirements
3 - 5 years relevant Pharmacovigilance/Pharmaceutical Industry experience.
Key Competency Requirements
• Working understanding of medical concepts and some 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 using organizational and interpersonal communication skills. Appropriately communicates 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)
• Ability to work well in cross-functional teams.
• Good collaborative and communication skills with scientific subject
matter.
• Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data,
postmarketing reports, scientific literature, and regulatory documents).
• Understand aspects and methods for data analysis, interpretation and
presentation.
• Possess good working skills in MS Word, Excel and PowerPoint,
including statistics
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1583128
Updated: 2024-07-05 03:04:38.178 UTC
Location: Madison-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb