Job Description
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For our EU regional headquarters (position can also be based in an EU affiliate) we are seeking highly qualified candidates to fill the position:
Senior Manager - PV Process Excellence Lead (m/f/x)
The Position:
The PV Process Excellence Lead in the BE/PMO supports PV process excellence at Daiichi Sankyo Europe (DSE) Clinical Safety and Pharmacovigilance (CSPV). The role involves strategic planning, improvement initiatives and special projects to optimize pharmacovigilance (PV) processes. The role collaborates with global CSPV teams, interdepartmental teams and external partners to design solutions and manage projects.
This role supports various strategic and operational initiatives to enhance the effectiveness and quality of pharmacovigilance activities, working closely with colleagues across CSPV globally and other key stakeholders. Additionally, the role supports budget management, tracks team goals and engages in Unit Planning activities.
- 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