Senior Manager, Safety Scientist (m/f/x)

We are seeking a highly qualified candidate to fill the position:

Senior Manager, Safety Scientist (m/f/x)

The Position:

The Senior Manager, Center of Excellence(CoE), scientist will support both Aggregate Report and Risk Managment CoE. For Aggregate Report CoE, scientist will support Daiichi Sankyo global aggregate reporting (AR) for investigational and post-marketed medicinal products within the Clinical Safety and Pharmacovigilance (CSPV) department. Since a global vendor has been engaged to manage aggregate reporting for the Daiichi Sankyo portfolio, this position is responsible for providing managerial leadership and oversight of AR activities and workflow (e.g. scheduling, kick-off meeting, generation of data, preparation, distribution, submission compliance tracking etc.) for the Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), and Periodic Benefit-Risk Evaluation Report (PBRER), including but not limited to generating of periodic line listings. For Risk Management CoE, the position will support activites related to non-company RSI and RMP tracking. For both functional areas, this position will handle aspects of process improvements, key performance indicators and global alignment, oversee reports in collaboration with product safety teams and the global vendor.

Roles and Responsibilities:

• Center of Excellence - Aggregate Reports

• Works with the Global Aggeragte Reports lead to guide and oversee the global vendor for aggregate reports, and ensure delivery of reports with level of quality and on time.

• Leads and manages generation and update of procedural documents related to CoE tasks

• Oversees generation of aggregate reports by vendor

• Center of Excellence - Risk Management

• Tracks development and implementation of local Risk Management Plans and additional Risk Management and Pharmacovigilance activities as part of the DSE CoE

• Collaborates with the global Risk Management Team within the CoE

• Management of RMP Tracker: Tracking and assessment of non-company RSI

• Project Management

• Serves as Project Management for assigned projects and ensures adherence to project timelines.

• Responsible for Signal Tracking and Deviation Management with safety related activities (e.g. RMP).

Personal Skills and Professional Experience:

• Bachelor’s degree at minimum required; PharmD or PhD preferred Required

• 5 years of experience with an advanced degree

• Possesses strong post marketing knowledge

• Experience in aggregate reports and risk management Required

• Strong communication skills

• Experience in project management and working in a matrix environment

• International, European and PV laws

• Fluent business English (oral and written) Medium