Senior Manager PV Operations

Daiichi Sankyo Europe

Munich, Germany

Purpose of the function

This position contributes to process management initiatives that are meant to make PV Operations processes more efficient/effective and provides support to ensure that daily business is fully executed and compliance targets are met. This position is responsible for representing DSE in PV Operational matters.The Senior Manager PV Operations ensures that all routine daily PV Operational activities are completed on time (ICSR/CRO Management) and meet the levels of excellence required. This position leads global sub-team(s); overseeing daily activities of that sub-team; assigning workload and monitoring outputs/progress.

Roles and Responsibilities

Responsibilities include leading of projects based on area of expertise;
Another responsibility is the oversight of PV Operations processes to promote full compliance, including the development and management of CAPAs related to ICSR management, together with the DSE CSPV PV Quality management team;
Core ICSR competencies:- Monitoring monthly compliance to ensure KPIs are met- Managing ICSR query escalation and vendor relationship interventions- Support daily workflow monitoring and managing of incoming and outgoing ICSRs- Manages complex internal and external ICSR queries- Provides case mentorship to PV Operations Associate- Develops and delivers training material- Case processing oversight of CRO/vendor, including case quality review- Handles complex spontaneous and clinical ICSR issues;
Compliance:- Represent PV Operations in audits and inspections- Review and approve CAPA for PV Operations- Create and review procedural documents;
In addition:- Brings operational insights to find solutions to PV Operational issues- Identifies areas of potential improvement and process optimization and suggests potential solutions- Proactively finds solutions to case processing and vendor issues- Interacts with the global CSPV team, DS affiliates, cross- functional departments and external partners.

Education & Experience

Education:

Master’s degree desirable; PhD preferred (Life Science, Pharmacology, Medicine).

Experience:

Minimum 7 years of experience in PV, including ICSR management, ideally with an advanced degree;
Proven leadership record including line management/supervisory experience beneficial;
Excellent understanding of PV regulations (European and International).