Senior Safety Scientist

Senior Safety Scientist

Daiichi Sankyo Europe

Multiple Locations, Europe

The position:

As a safety scientist you will provide scientific expertise and support proactive safety surveillance and risk management activities in conjunction with the Product Safety Lead Physician for Quizartinib and cross-functional team(s) in support of benefit risk profile during post-marketing phase.

Key responsibilities:

Support Quizartinib product maintenance during post marketing including:

• Support of post marketing risk management activities (RMP, aRMM);
• Support generation of periodic reports (PSUR, Regional aggregate reports) and responses to health authority requests;
• Collaborate with Product Safety Lead for set-up and analysis of Post-marketing studies/registries;
• Review of scientific literature;
• Support of the PSMF generation for product related information;

Risk management and Safety communication:

• Support for implementation of strategy for risk minimization;
• Support of product safety physician for signal detection;
• Development of strategy for communication of safety information;
• Development of safety communication documents and aggregate safety reports;
• Responsible for Signal Tracking and Deviation Management with safety related activities (e.g. RMP).

Professional experience and personal skills:

• Bachelor’s degree at minimum required; PharmD or PhD preferred;
• Professional experience of at least 5 – 7 years in a similar position within the pharmaceutical industry;
• Experience in summarizing and presenting safety data;
• Possesses strong clinical safety & PV knowledge;
• Experience in project management and working in a global matrix environment;
• Experience in International, European and Pharmacovigilance laws;
• Oncology product experience is preferred;
• Fluent English in written and spoken.

Apply Now

More Job Searches

Multiple Countries      Clinical Research      Pharmacovigilance and Medical Information      Daiichi Sankyo Europe