Roche
Healthcare
PatientSafetyPartner
“Patient Safety Partner at Roche. Skills: Patient Safety, Pharmacovigilance, Risk Management. Support implementation, maintenance and oversight of local PV system. Ensure efficient and effective PV system”
What You'll Achieve.
Ensure an efficient and effective PV system; Safeguarding our License to Operate; High-quality implementation of global and local safety solutions; Optimize patient outcomes
Industry & Context.
Solves problems within own discipline; Removes or reduces obstacles/barriers
What They're Looking For.
Must Have
Degree in life science or healthcare-related discipline, Proven experience in pharmacovigilance, Understanding of decision-making in the local & global PV ecosystem, Understands the basics of strategic planning, Pro-active and strategic able to think in systems, Focuses on the fundamentals of execution, Actively contributes ideas and expertise, Shares experiences and best practices, Influence to gain support for initiatives, Understands the structure, key roles and responsibilities of internal stakeholders, Builds trusting relationships, Communicates timely and effectively, Demonstrates an abundance mindset, Solves problems within own discipline, Prioritizes own work, Ability to seek information to understand high level drug development, Basic understanding of drug development, Basic understanding of pharmaceutical industry, Basic understanding of commercial development, Basic understanding of financial standing, Understands regulatory requirements, Can clearly speak about process during an audit or inspection, Seeks feedback on their performance, Grows confidence in providing appropriate feedback
Nice to Have
Experience in other affiliate medical functions, Experience in global functions such as Clinical Safety
What You'll Do.
Support implementation
maintenance and oversight of local PV system
Ensure efficient and effective PV system
Comply with global Roche and local PV requirements
Support execution of IPS & Affiliate’s Patient Safety strategies
Ensure high-quality implementation of safety solutions
Demonstrate leadership in ownership
Execution of safety-related activities
Monitoring of safety profile of Roche products
Safety risk management
Identify opportunities to optimize PV system
Data collection for ICSRs
Signal Detection & Signal Management
Submission of aggregate safety reports
Pharmacovigilance Agreements
Risk Management and Safety Communication
Manage studies with PV implications
Safety Labeling and PV Commitments
Maintain Local Pharmacovigilance System Master File
Shape country PV regulations
Promote regulatory reliance and international harmonization
analyze and share safety insights
Implement global safety solutions locally
Execute product safety launch readiness activities
Support country-level risk management strategy
Ensure compliant and transparent PV communications
How You'll Work.
Team & Collaboration
Partnership with key stakeholders; Collaboration within relevant networks; Collaboration with Medical Affairs; Collaboration with cross-functional team; Contribute to local and above country projects; Influence to gain support for initiatives; Builds trusting relationships with internal stakeholders
Communication Scope
Communicate timely and effectively; Clearly speak about process during an audit or inspection
Process & Methodology
Contribute to plans, Manage personal tasks, Reporting progress
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