Associate Director- Patient Safety Scientist - Princeton, United States - Bristol-Myers Squibb

Bristol-Myers Squibb

Verified Company

Princeton, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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.

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

Position Summary
Leads Safety Data Review (SDR) Teams.

Independently performs core signal detection activities and elevate program or portfolio issues impacting key Safety Management Team (SMT) programs, priorities, resources, and milestones.

Drafts the early safety strategy plan, the Early Development Safety Roadmap (EDSR).

Authors safety data query responses, author and contribute to specific PV sections of the Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), and health authority (HA) submission documents for new and expanded indications (Filing Activities).

Ensures pharmacovigilance regulatory compliance.

Mentors less experienced scientists and teams in aspects of project management, SMT requirements, core signal detection, safety data query responses, and contributions to specified PV sections of the PBRER and DSUR, as appropriate to meet individual or group of SMT/sub team needs.

Position Responsibilities:

General Product Support

Leads signal detection activities for a product's emerging safety profile.
Provides strong medical writing support for PV sections of safety aggregate reports (eg, DSUR, PBRER) and analyzes data for the RSI section of the IB. Collaborates with MSAP to author and analyze data for ad hoc responses to health authorities.
Contributes to the development of the strategy for signal evaluation (eg, caseseries, literature review, HA/ claims database). Documents signal assessment in a Signal Report drafting a preliminary conclusion.
Develops strategies for safety data collection in clinical trials to further characterize adverse events of interest.
Analyzes data and prepares documentation to support label updates for assigned products.
Supports the European Union Qualified Person for Pharmacovigilance (EU QPPV) or other regional or local Qualified Person for safety issues relating to assigned products.
Applies 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.
Collaborate with the Pharmacovigilance Centre of Excellence (PVCoE) to develop report requirements and other customized safety data visualizations.
Serve as liaison to Medical teams for AIMS (Asset/Indication Medical Strategy), publications, and investigator sponsored research

Clinical Development & Post Marketing Product Support

Leads core surveillance activities, signal assessment according to the product stage of development for multiple compounds, with oversight, as needed.
Lead the creation and updates of EDSR proactively collect, assess, identify, characterize, manage, and minimize emerging safety concerns across all aggregated clinical trials of a product during its development.
Leads SDR Teams in the review and evaluation of clinical data to support signal detection. Appropriately elevates issues impacting key SMT activities, milestones, and documents to the SMT Chair with limited or no oversight, as needed.
Review of clinical documents for safety content (i.e. protocols, protocol amendments, clinical study reports).
Contributes to presentations for external review committees (i.e. DMC).
Safety strategy preparation for presubmission meetings
Contribute to relevant safety documents such as the /Company Core Data Sheet (CCDS)/ label, Briefing book and Summary of clinical safety.
Author HA safety query responses
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 limited or no oversight, as needed.
Provides guidance to junior scientists' for reviewing and authoring of safety data/ad hoc queries and other documents.
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