Director Process Governance Compliance - Madrid, España - Novartis

Novartis

Empresa verificada

Madrid, España

hace 2 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

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, to drive performance and quality, to 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 highquality 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 processrelated 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 preapproval 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 ou will bring to the role:
Life Sciences/ Pharmacy/ Medical Sciences or equivalent degree
Fluent English (oral and written). Knowledge of other languages are 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, selfstarter 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