Sr Risk Management Scientist, Global Pharmacovigilance
GE HealthCare, Wind Lake, WI, United States
The Senior Risk Management Scientist provides scientific and operational support for global pharmacovigilance risk management and safety signal activities across the product lifecycle. The role supports the execution of risk management strategies, safety signal detection and evaluation, and regulatory compliance in line with global pharmacovigilance requirements. This position contributes to the development of Risk Management Plans, safety analytics, and governance deliverables, and supports preparation of materials and presentations for the Product Safety Review Board (PSRB). Reporting to the Head of Global Drug Safety and Risk Management, the role works cross‑functionally to ensure consistent, data‑driven risk oversight and effective safety communication.
Responsibilities
Serve as an operational leader of the Drug Safety & Risk Management (DSRM), driving oversight, implementation, and tracking of all global PV risk management obligations, commitments, and risk minimization measures.
Coordinate and track reporting of safety issues to Product Safety Review Board (PSRB), Quality Management Review (QMR), and PV Leadership in compliance with internal procedures.
Interpret safety data trends in collaboration with Senior Medical Director and statistician, ensuring accurate integration of risk assessment into product labeling and RMPs.
Lead and coordinate bi‑weekly Safety Review Team meetings and contribute to the preparation of cross‑functional Signal Investigation Meetings.
Develop analytical tools, standard outputs, and data visualizations that support comprehensive signal evaluation.
Review Signal Detection outputs and notify Drug Safety & Risk Management of safety observations of interest.
Serve as an Administrator in Veeva RIM for Safety Signal Workflow and UAT.
Coordinate and contribute to periodic ADR trending review in collaboration with Medical Director.
Collect data and prepare monthly/quarterly KPIs related to Safety Signals and ADR trending.
Author and lead development of Risk Management Plan(s) and associated regulatory documents in accordance with Good Pharmacovigilance Practices and regional regulatory expectations.
Work closely with cross‑functional teams (Clinical Development, Medical Affairs, Regulatory Affairs) to ensure alignment of GEHC’s global position for PV risk management processes.
Collaborate with Senior Risk Management Director, PV Physicians and PV Scientists on regulatory submissions for MAA to reflect risks appropriately.
Contribute to risk components of Aggregate reports like DSUR, PBRER and other periodic assessments, ensuring integration of current risk profiles and emerging safety data.
Perform other duties related to the position as necessary and as defined in SOPs or at the request of supervisor.
Qualifications
Advanced clinical degree (e.g., MD, DO, NP, PA, PharmD, PhD in a health‑related field) required.
Significant experience in pharmaceutical/biotechnology PV, including clinical trial and post‑marketing experience; global experience preferred.
Substantial experience in PV/Safety.
Strong knowledge of FDA, EU, ICH guidelines and regulations governing pharmacovigilance.
Strong knowledge of safety signal evaluation and responses to safety requests from Health Authorities.
Desired Skills
Strong oral and written communication skills.
Strong interpersonal and leadership skills.
Demonstrated ability to analyze and resolve problems; led programs/projects.
Ability to document, plan, market, and execute programs.
Established project management skills.
Strong track record of scientific and analytical thinking.
Additional Information Relocation Assistance Provided: No
Equal Employment Opportunity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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Responsibilities
Serve as an operational leader of the Drug Safety & Risk Management (DSRM), driving oversight, implementation, and tracking of all global PV risk management obligations, commitments, and risk minimization measures.
Coordinate and track reporting of safety issues to Product Safety Review Board (PSRB), Quality Management Review (QMR), and PV Leadership in compliance with internal procedures.
Interpret safety data trends in collaboration with Senior Medical Director and statistician, ensuring accurate integration of risk assessment into product labeling and RMPs.
Lead and coordinate bi‑weekly Safety Review Team meetings and contribute to the preparation of cross‑functional Signal Investigation Meetings.
Develop analytical tools, standard outputs, and data visualizations that support comprehensive signal evaluation.
Review Signal Detection outputs and notify Drug Safety & Risk Management of safety observations of interest.
Serve as an Administrator in Veeva RIM for Safety Signal Workflow and UAT.
Coordinate and contribute to periodic ADR trending review in collaboration with Medical Director.
Collect data and prepare monthly/quarterly KPIs related to Safety Signals and ADR trending.
Author and lead development of Risk Management Plan(s) and associated regulatory documents in accordance with Good Pharmacovigilance Practices and regional regulatory expectations.
Work closely with cross‑functional teams (Clinical Development, Medical Affairs, Regulatory Affairs) to ensure alignment of GEHC’s global position for PV risk management processes.
Collaborate with Senior Risk Management Director, PV Physicians and PV Scientists on regulatory submissions for MAA to reflect risks appropriately.
Contribute to risk components of Aggregate reports like DSUR, PBRER and other periodic assessments, ensuring integration of current risk profiles and emerging safety data.
Perform other duties related to the position as necessary and as defined in SOPs or at the request of supervisor.
Qualifications
Advanced clinical degree (e.g., MD, DO, NP, PA, PharmD, PhD in a health‑related field) required.
Significant experience in pharmaceutical/biotechnology PV, including clinical trial and post‑marketing experience; global experience preferred.
Substantial experience in PV/Safety.
Strong knowledge of FDA, EU, ICH guidelines and regulations governing pharmacovigilance.
Strong knowledge of safety signal evaluation and responses to safety requests from Health Authorities.
Desired Skills
Strong oral and written communication skills.
Strong interpersonal and leadership skills.
Demonstrated ability to analyze and resolve problems; led programs/projects.
Ability to document, plan, market, and execute programs.
Established project management skills.
Strong track record of scientific and analytical thinking.
Additional Information Relocation Assistance Provided: No
Equal Employment Opportunity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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