Company
RiskSurveillanceLead
“Risk Surveillance Lead. Skills: Risk Surveillance, Risk-Based Quality Management (RBQM), Cross-functional coordination, Vendor/stakeholder management, Operational metrics, Resource planning, Continuous improvement. Driving the adoption of RBQM practice at trial level. Overseeing the implementation and continuous improvement of RBQM”
What You'll Achieve.
Driving the adoption of RBQM practice at trial level; Overseeing the implementation and continuous improvement of RBQM; Enabling a comprehensive clinical quality (GCP) risk governance; Achieve maximum benefit from RBQM methodology
Industry & Context.
Root cause identification; Mitigation strategies; Analyzing data; Identifying patterns; Making recommendations for improvement
Novartis cannot sponsor visas for these locations, Relocation is not available for these locations, On site expectation of 12 days per month/ave. 3 days per week in the office.
What They're Looking For.
Must Have
Minimum of 4 years of experience in the pharmaceutical or CRO industry, Robust understanding of the drug development process and clinical trial execution, Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP), Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions, Demonstrated ability to analyze data, identify patterns and make recommendations for improvement, Demonstrated ability to effectively lead cross functional team meetings, Experience forming cross-functional interpersonal skills, Supports a culture of continual improvement and promotes knowledge sharing, Ability to influence without authority, Thinks challenges the status quo, English: fluent written and spoken
Nice to Have
Preferred minimum of 1 years of experience in Risk Based Quality Management, Knowledge of RBQM IT systems or other data analytic systems
What You'll Do.
Driving the adoption of RBQM practice at trial level
Overseeing the implementation and continuous improvement of RBQM
Surveillance of quality risks across assigned trials and programs
Facilitating trial protocol risk assessment across multiple cross-functional domains
Defining quality tolerance limits (QTLs)
Evaluating risks based on likelihood
Ensuring mitigation strategies/plans are defined
and archiving study-specific risk management documentation (e.g.
Integrated Quality Risk Management Plan - IQRMP)
Partnering with the RBQM system configuration team
Conducting periodic central surveillance of aggregate data
Identifying emerging risks and/or issues
Facilitating risk review meetings and discussions
Supporting and participating in internal and external audits and inspections
Collaborating with training departments to support training initiatives
Identifying and sharing lessons learned
and process improvement opportunities
How You'll Work.
Team & Collaboration
Works within a matrix environment; Partners with the RBQM system configuration team; Facilitates risk review meetings and discussions with study and potentially program team members; Collaborates with training departments; Leads study teams to understand and follow best practices
Communication Scope
Fluent written and spoken English
Process & Methodology
Process management, Cross-functional coordination, Vendor/stakeholder management, Resource planning
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