Director Process Governance Compliance & Risk is accountable for establishing, maintaining, and optimizing the process governance, assessing pharmacovigilance system regulatory risks, and driving global pharmacovigilance process enhancements to support key technology and business transformation efforts in close collaboration with Head Patient Safety Operations & Compliance. This includes responsibility for quality management, oversight, and enforcement of processes and compliance reporting described in the pharmacovigilance system to meet Health Authority expectations.
Major Accountabilities Responsible to design and drive the governance of processes owned by Sandoz and strategic suppliers and assure conformity with Sandoz group policies and worldwide regulatory requirements.
Chair PV system performance overview committee.
Assess the risk for the company regarding worldwide pharmacovigilance and device vigilance systems by overseeing the management and implementation of corrective and preventive actions (CAPAs).
Develop and maintain efficient and uniform processes and global operating procedures (GOPs)/standard operating procedures (SOPs) to assure that worldwide regulatory requirements for marketed and development pharmaceutical products are met in consultation with relevant GOP/SOP governing body where applicable.
Collaborate with other Sandoz global line functions and countries to develop synergies, drive performance and quality, identify process improvement areas as well as development of respective process changes, and ensure compliance with the Health Authority expectations.
Ensure implementation of GOPs/SOPs at global, regional, and local levels to support consistency in policies and processes in collaboration with Quality Assurance (QA). This includes assuring proper training and communication.
Partner with Sandoz Group functions (including Clinical, Regulatory Affairs, Marketing, Communication) and QA, to ensure integrated high-quality processes that meet regulatory requirements. This includes representing Sandoz patient safety on steering and/or compliance committees where relevant.
Implement the foundational aspects of the Sandoz patient safety quality manual to have a sustainable quality management system in place.
Oversee Pharmacovigilance System Master File (PSMF) metrics ensuring that Sandoz group is compliant with worldwide regulations and company policies & procedures are followed.
Set strategy and drive initiatives within Sandoz patient safety and with Global line functions from all Sandoz Divisions to standardize PSMF metrics.
Monitor quality of safety information and compliance for all relevant processes through tracking of key performance indicators.
Drive training excellence and training compliance and ensure process-related change management and communications strategies are in place.
Interacts with Health Authorities worldwide to address current pharmacovigilance processes, emergence of new safety regulations, and during marketing authorization pre-approval Good Clinical Practice and post marketing Pharmacovigilance inspections.
Drive and manage change/adjustment of organizational structure and processes.
Deputize for Head Patient Safety Operations & Compliance in key global leadership forums representing internal and external forums including senior leadership meetings at Sandoz.
Commitment to Diversity & Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements What you will bring to the role:
Life Sciences/ Pharmacy/ Medical Sciences or equivalent degree.
Fluent English (oral and written). Knowledge of other languages is desirable.
Ten years of experience in drug development, including clinical safety, pharmacovigilance, and closely related areas of development.
Seven years of global people management and development experience required.
Sound knowledge of global safety and pharmacovigilance regulations worldwide.
Demonstrated success in resource planning and management.
Proven ability to work and handle multiple tasks independently and effectively.
Ability to lead and deliver cross-divisional initiatives.
Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal), and presentation skills.
Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.
Excellent planning, organizational, and computer skills.
Division: SANDOZ
Business Unit: COMMERCIAL OPS EUROPE SZ
Country: Spain
Work Location: Madrid
Company/Legal Entity: Sandoz Farmacéutica, S.A.
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
Shift Work: No
Early Talent: No
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