Lead of Eu Pharmacovigilance Database Management

vor 3 Wochen

Munich, Deutschland Daiichi Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
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 Daiichi Sankyo Europan Headquarters in Munich or in our affilitates in Europe we are looking for a

**Lead of EU Pharmacovigilance Database Management and Analytics (DBMA) (M/F/x)**:
**The position**:
Leads the Pharmacovigilance Database Management and Analytics (PV DB Management and Analytics) team at Daichi Sankyo Europe, also leads workstreams of global DBMA or global projects as a designee of the Global Sub-function Lead of DBMA. The DBMA team is accountable for oversight and management of the Global Safety Database and related Data Analytic tools (in collaboration with IT and database/systems vendors)

**Roles & responsibilities**:

- Management of Global Safety Database:

- Ensures the DBMA team are trained to develop appropriate configuration of the safety database.
- Maintains oversight of and accountability for DSE PV systems and represents DSE in strategic discussions regarding global PV system/technology related activities, including new system installation, configuration and integration with other companion systems.
- Identifies and develops new systems/databases to meet future business needs and expectations of the Regulatory Authorities utilizing the latest technology.
- Ensures the system support vendors are qualified, high performing and motivated to achieve the business objectives.
- Implements advanced technologies (e.g. E2B import, Axway configuration) and promotes process automation and digitalization for business process improvements.
- Collaborates with other sub-functions within CSPV, namely with Medical Safety, PV Operations, PV Affiliate and Partner Management, PV Quality Management and ensures that all safety database configuration (including reporting rules) is well maintained to meet departmental needs.
- Manages reported PV system issues including troubleshooting, liaising with IT Application Support team and helpdesk, and vendors as appropriate.
- Ensures appropriate company processes are in place for timely and accurate reporting of PV information for expedited, aggregate and ad-hoc reporting needs and assists in management of PV audit/inspections as an SME for the safety database and associated PV systems.
- Data Analytics/PV Reports:

- Maintains oversight of system tools for provision of data analytics and ensures team are appropriately trained to support generation of PV reports as per the request by the PV SMEs (e.g. Safety surveillance/Medical assessment, Health Authority & Partner requests, Periodic Reports, KPIs/Metrics reports, reconciliation outputs for affiliates/third parties, Audit/Inspection outputs) in a regular, timely and automated manner.
- Ensures team is able to assist in the delivery of non-standard safety reports, which enables SMEs to find solutions for complex requirements/assessment (e.g. Health Authorities, data integration from multiple sources/systems).
- Works with the DBMA team and SMEs to further develop outputs and formats for presentation of data to facilitate data interpretation and decision making (e.g. KPI dashboards).
- People/Team Management:

- Leads, manages and mentors staff, monitors workload and assigns responsibilities as appropriate to maximise the team outputs and achieve business objectives. Directs the activities of DSE DBMA team members within global projects, including workstream assignments and ensuring key milestones are reached. Provides opportunities for individual growth, prepares individual development plans for the members within the team and supports their execution.

**Professional experience & education**:

- Bachelor’s degree at minimum required; Master, Ph. D preferred
- Minimum 10 years’ experience in Pharmacovigilance systems
- Advanced functional and technical understanding of PV systems and their integration; experience in development of PV software, handling database structure and validation with industry standard systems (Oracle, Argus or LifeSphere Mulitivigilance (LSSMV) )is required. Knowledge of programming (e.g. SAS, SQL) is preferred.
- Detailed and in-depth understanding of both focus areas within the DSE and global DBMA team
- Possesses strong understanding of global PV regulations; the differences between geographical regions and awarene

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