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Senior Process Governance & Training Excellence Manager

Senior Process Governance & Training Excellence Manager

NOVARTIS

7 - 12 years

9 - 14 Lacs

hyderabad

Posted:4 hours ago| Platform:

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Skills Required

change management team management lms matrix networking project management pharmacovigilance subject matter expert operations process management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Develop, and implement effective procedural updates and training strategies in line with the Patient Safety and Pharmacovigilance (PSPV) needs and regulatory expectations. Oversee Process Governance and Training Excellence (PGTE) processes and identify areas of improvement and streamlining. Work with leaders and process owners across PSPV to identify change management needs as it relates to process changes.

About the Role

Major accountabilities

Implement the PGTE operational strategy and standards across PSPV.
Act as a subject matter expert (SME) for change management and support Lead SMEs / Process Owners in the development of procedural document training strategies for process change proposals.
Deputize for Process Management Committee (PMC) Chair and Procedural Training and Governance Board (PTGB) representative as needed.
Drive continual simplification and improvements for efficiency in the Training and Procedural Governance Processes.
Lead integration workstreams during mergers, spin-off and acquisitions as the PGTE representative.
Work with Process Owners and SMEs to develop, implement, document and ensure appropriate applicabilities of individual strategies for the respective process updates.
Establish and maintain functional training infrastructure within the Learning Management System, and all required processes to allow optimized training of all PSPV associates.
Act as a subject matter expert on process governance, change management, and training during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
Maintain training compliance oversight, including presentation to relevant oversight boards.
Collaborate with QMS system owners to ensure effective management of procedural and functional trainings within the systems impacting PGTE.

As a PGTE process owner

Own the content and lead the updates for the Adverse Event corporate training
Ensure alignment of all PGTE processes within both corporate and GDD standards
Actively surveil and analyze emerging regulations, perform impact assessments and drive process changes required to ensure timely implementation and ongoing compliance of owned process to global regulatory requirements.
Lead the development and maintenance of PGTE procedural documents including all required functional trainings and ownership of relevant PSMF sections and annex

Key performance indicators

Implementation of strategies which result in a measurable increase in the efficiency of the process by which change is managed
Implementation of strategies which result in a measurable increase in the quality of procedural documents and the time required to achieve roll out.
Processes and procedural documents that are compliant with worldwide regulatory requirements and Novartis policies

Minimum Requirements
Work Experience

Minimum 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance
Leadership and (matrix) management experience.
Ability to lead and deliver cross-functional initiatives in a matrix environment.
Strong organizational and project management skills.
Strong negotiation and communication skills and ability to operate effectively in an international, matrix environment
Ability to lead global and cross-functional work groups; deal and interact with a wide variety of people at all levels.
Excellent document writing skills.
Experience of working with and supporting a team; ability to coach and mentor.
Critical Negotiations.
People Challenges.
Operations Management and Execution.
Collaborating across boundaries.
People Leadership.

Skills

Clinical Trial.
Databases.
Employee Training.
Process Governance.
Governance boards.
Pharmacovigilance.
Project Management.
Reporting.
Safety Science.
Team Management.

Languages

English.

Benefits and Rewards

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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Senior Process Governance & Training Excellence Manager