Senior Manager - PV Process Excellence Lead (m/f/x)

• Support the execution of DSE CSPV and global CSPV initiatives focused on PV process excellence.
• Communicate effectively with key global and cross-functional stakeholders to identify interdependencies and collaboration opportunities in PV.
• Collect data and perform analyses to support informed decisions that drive PV process improvements.
• Support activities to identify areas within pharmacovigilance that require process optimization; leveraging client needs, best practices and benchmarked performance measures.
• Lead PV process mapping and design workshops, work sessions and interviews with stakeholders to gather business requirements.
• Contribute to gap analyses highlighting current state, future state, CSPV needs and best practices in PV.
• Contribute to impact analyses of PV process redesigns to develop efficient and compliant PV processes, ensuring these adhere to scope and strategic goals.
• Contribute to discussions to identify root causes of PV operational and quality issues to develop actionable solutions.
• Support the preparation of business requirements and generating of documentation for PV-related RFIs and RFPs.
• Collaborate to identify performance metrics for current-state PV processes.
• Contribute to establishing and tracking performance goals for future-state processes based on CSPV needs and best practices.
• Plan, manage, and coordinate PV-related projects within DSE CSPV and global CSPV, ensuring timely and quality deliverables.
• Collaborate with CSPV colleagues to drive PV projects toward achieving business results.
• Support budget planning and monitoring activities related to PV projects.
• Monitor and manage scope change requests and contribute to periodic progress reports against budget and timelines.
• Support the prioritization of PV projects/initiatives to optimize CSPV effectiveness and quality, both regionally and globally.

• University degree in medical science, pharmacy, or a related discipline.
• Minimum of 5 years of experience in Drug Safety/Pharmacovigilance experience, including both investigational and marketed products.
• Broad and in-depth knowledge of pharmacovigilance processes and regulatory requirements in the EU plus awareness of other pharmacovigilance regulations globally.
• Strong project management skills and familiarity with project management methodologies and best practices considered advantageous in this role.
• Ability to define and monitor KPIs to achieve optimal PV process performance.
• Experience with PV process optimization and business process redesign.
• Familiarity with Good Clinical Practices, patient privacy laws and other applicable local regulations.
• Certification in Project Management (e.g., PMP, PRINCE2) preferred.
• Previous PV auditing experience preferred.

Personal Skills:

• Excellent critical and lateral thinking skills and problem-solving skills, experience in conducting root cause analysis to identify and effectively address issues independently.
• Strong organizational and time management skills.
• Ability to collaborate and negotiate with internal and external stakeholders and across all levels.
• Strong communication and negotiation skills, including the ability to prepare and present information clearly to CSPV leadership.

• Excellent Benefits
• Work-Life-Balance
• Growth and Development
• Health and Wellbeing Support