Associate Director Safety Science

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Job Information

Bristol Myers Squibb

Associate Director, Safety Science

in

Summit

New Jersey

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Key Responsibilities will include, but are not limited to, the following:

General Responsibilities

Provides support to LPSP (Lead Product Safety Physician) in activities relating to monitoring and management of unapproved and approved product's emerging safety profile

May present at the Safety Management Team (SMT) with support of the LPSPDrafts materials (Slides, etc.) in preparation of Company Safety Committee (CSC) meetings

Leads signal detection activities (evaluation and tracking) by conducting review and synthesis of key safety information

May lead ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile

Provides support to LPSPs for Product Quality issue and inquiries from external department (e.g. Legal, clinical, RA, etc.)

Provides input and support safety publication strategy

Trial Safety Support

Serves as the Lead Safety Scientist for several compounds and may oversee the operational execution of all safety-related clinical trial activities

May lead the strategy for surveillance activities, signal assessment, and regulatory safety requests for multiple compounds and/or key registrational clinical trials (in development or investigator-initiated)

May oversee and completes study-level activities (as needed): risk/benefit assessment for EU CTAs, protocol and statistical outputs (e.g. tables, listings & graphs [TLGs])

Authors or provides content for safety sections of documents such as Investigator's Brochures, Aggregate Safety Reports (PSUR/DSUR), Annual Reports, Standard Risk Language for ICFs, Company Core Data Sheet and Risk Management Plans

Provides support for the lead safety physician in the strategy and authoring of integrated submission documents

Obtains and reviews integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the lead product safety physician across multiple compounds

Assists the lead product safety physician with the management of the product's benefit/risk profile

Post-marketing Support

Contributes to development of signal detection strategy with consideration for integrating quantitative data mining methods and qualitative approaches

Provides support to LPSP in development of risk mitigation strategies

Leads Safety Topic Review development and authorship

Leads ad-hoc regulatory safety requests preparation by obtaining and analyzing data from various sources to assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile

Authors or provides content for safety sections of documents such as aggregate safety reports (PSUR/DSUR), Company Core Data Sheet, Risk Management Plans, and Events of Interest Surveillance Documents

Drafts and conduct safety labeling activities for assigned products

Performs literature review and QC

Compound Level Safety Support

Authors or provides content for safety sections of documents such as Investigator's Brochures, aggregate safety reports (PSUR/DSUR), annual reports, Standard Risk Language for ICFs, Company Core Data Sheet and Risk Management Plans

Provides support for the lead safety physician in the strategy and authoring of integrated submission documents

Obtains and reviews integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the lead product safety physician across multiple compounds

Assists the lead product safety physician with the management of the product's benefit/risk profile

Departmental Activities

Leads preparation for regulatory inspections with evaluation of current processes and documentation, and may serve as the SME

Liaises with all TA staff and maintain an effective and collaborative product safety team

Trains and mentors junior safety scientists and/or other safety staff

Cross-Functional Activities

Leads various process improvement and cross-functional initiatives for both Safety Science and GDRSM, including SOPs and Work Practices

Leads various process improvement and cross-functional initiatives for both Safety Science and GDRSM, which may include authorship of SOPs and Work Practices

Leads interactions with key line functions in support of safety activities between Safety Science and clinical R&D, Biostatistics, Data Management, Trial Management, Medical Affairs, or Safety Information Management

Key Relationships:

Department staff, peers and management ,

Lead Product Safety Physicians ,

Clinical Operations, Data Management ,

Clinical Research Scientists ,

Medical Writing ,

Case Management / LDSO ,

Global Medical Affairs ,

Regulatory Affairs ,

Clinical Quality Assurance

Governance;

Participate and/or provide input to materials and strategies at meetings including but not limited to:

SMT - Safety Management Teams

DMC - Data Monitoring Committees - internal or external

Product Development Team

Clinical Study Team

Risk Management

Qualifications/Experience

Education:

Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience

Relevant Industry Experience:

At least 6-8 years of relevant pharmaceutical industry experience, with at least 4 years of drug safety experience. Previous experience in Safety or Clinical Development or Operations is required

Key Leadership Behaviors/Competencies:

Decision-Making & Change Agility ,

Conflict Management ,

Relationship Management ,

Communication/Writing ,

Time Management & Prioritization ,

Results-Drive

Self-Awareness & Perspective, Organization Skill & Political Savvy

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Company:

Bristol-Myers Squibb

Req Number:

R1526773_EN

Updated:

2020-07-02 00:00:00.000 UTC

Location:

Summit,New Jersey

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com