Countries & Regions Process Excellence & Operations Manager

The Countries and Regions (C&R) Patient Safety (PS) Process Excellence & Operations Manager is instrumental in aligning global and local pharmacovigilance processes to ensure compliance and efficiency.
This role is pivotal in supporting process improvements, facilitating effective communication, and supporting strategic initiatives within the organization. By ensuring that organizational processes meet both global standards and local regulatory requirements, the C&R PS Process Excellence & Operations Manager plays a crucial role in maintaining a compliant pharmacovigilance system.
Additionally, the C&R PS Process Excellence & Operations Manager supports the C&R organization by collecting necessary data, preparing comprehensive analyses, and maintaining oversight across the entire C&R organization.
As member of C&R Leadership Team, support C&R Leadership in driving various glob-al/regional initiates to promote process governance, excellence and simplification across local PS team.

• Support and enable the implementation of global PS processes in countries consistently, adhering to the global PS process scope and requirements.
• Collaborate with Global PS process owners, countries (Country PS Responsible), and regions (Regional PS Leads) to ensure global processes cover locally required PV activities.
• If global processes cannot fully cover local PV activities due to specific legislative requirements, support the development of local processes to amend the global PS process in collaboration with CPSR, Regional PS Leads, and process owners.

• Ensure all deviations from global processes are described, justified, and correctly implemented.
• Monitor the effectiveness of implemented local processes and make recommendations for improvements.
• Facilitate training and support for local teams to ensure understanding and adherence to global and local PS processes.
• Support C&R Leadership with business process management by facilitating activities related to business process development, implementation, maintenance and improvement.
• Support C&R Leadership by fielding and responding to routine request for clarity or instruction from CPSRs.
• Support process simplification activities to ensure processes are fit for purpose, eliminating inefficiencies and redundant complexities by implementing new ideas, ways of collaboration, and modern technologies.

• Serve as communications lead within C&R, ensuring clear, consistent and timely messaging is shared and understood by the entire C&R team
• Facilitate discussions and decision-making by providing expert insights and recommendations.

• Support and manage the collection of information from individual countries or regions as needed and prepare consolidated reports.
• Ensure all oversight data (KPIs, CPSRs Dashboard) are received on time from owners and uploaded into the designated C&R repository.
• Oversee and ensure that countries maintain the contact details tracker and prepare the monthly transmittal sheet (one-pager) on time every month.
• Represent C&R in various process and oversight committees and boards.
• Support the preparation and consolidation of data for monthly PV system oversight meetings.
• Collaborate with Global C&R PS Heads to support, facilitate, prepare, and manage C&R Extended Leadership meetings.
• Collaborate with Sandoz strategic service providers and preparing efficient meetings with all agenda points supported by relevant data from both the external partner and Sandoz perspectives.
• Provide contingency deputization support for Regional PS Leads, to support business continuity within C&R PS on urgent needs basis.

• Support and/or manage various regional and global PS initiatives and projects as agreed with Global C&R PS Heads.

• Support CPSRs and Regional PS Leads in preparation of audits and inspections and serve as subject matter expert on global and local PS process oversight.

What you ll bring to the role: Essential Requirements:

• Degree in Health Sciences or higher, including medical degree, pharmacy, or nursing
• Minimum 7 years in pharmacovigilance, pharmacovigilance requirements, or regulatory compliance.

• Thorough understanding of the Pharmacovigilance System and its purpose.
• Strategic and critical thinking skills for establishing pharmacovigilance oversight worldwide.
• Advanced experience in working with multi-disciplinary or cross-functional teams and influencing others in a matrix organization.
• Proven ability to handle multiple tasks independently and effectively.
• Excellent communication, interpersonal, and negotiation skills (confident and articulate).
• Quality and focus oriented.
• Results-driven, self-starter with a proactive working style; committed, accountable, and able to maintain transparency under pressure.
• Culturally sensitive, patient yet persuasive, and aligned with Sandoz values.