Senior Director Safety Physician Specialty Medicines (m/f/x)

Passion for Innovation. Compassion for Patients.

Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

For our headquarter in Munich we are seeking highly qualified candidates to fill the position of

Senior Director Safety Physician Specialty Medicines (m/f/x)

Purpose of the function:

Performs medical review of ICSRs supervising the global vendor and also supports other sub-functions of the Centers of Excellence (e.g. Risk Management, Signal Detection). The position serves as regional Medical Reviewer working within a global team (e.g. US, Japan) with solid medical knowledge in both oncology and speciality medicines therapeutic area. Active participation in daily medical review activities. Serves as primary contact among DSE CSPV for medical review activities, and contributes to signal detection and safety monitoring activities. The position works with the respective DSE product safety leads, the medical review teams from other sites (DSJ, DSI) for global alignment and DSE PV Operations team to achieve proactive and continuous improvement. The position reports to the Medical Safety Centre of Excellence Lead DSE.

Responsibilities:

• Co-leads DSE CSPV Specialty Medicines product team to manage safety profiles 
• Engage with the global Specialty Medicines product teams to manage safety profiles 
• PV strategic guidance for preparation of safety relevant parts of submission documents for marketed SM products as requested by European authorities and for products in development
• Safety surveillance and risk management activities for assigned product portfolio (e.g. Oversees the development, maintenance of Safety monitoring plan, execute on safety monitoring activities including  development of and submission of relevant RMPs, aggregate reports (PSURs/DSURs) for designated products.  
• Responsible for the safety content of other relevant safety documents (e.g. Safety sections of the CSR and submission dossier, CCDS, SmPC, Signal detection reports) 
• Support Specialty Medicine Therapeutic Area Lead evaluation for Specialty Medicine products and creation of response documents for health authority requests
• Medical-scientific analysis of clinical trials, Post Authorization Safety Studies (PASS) and non-interventional studies (NIS) concerning pharmacovigilance aspects
• Manages regulatory responses to emerging safety issues and provides strategies to address these
• Implements risk mitigation for designated products and oversees the global communication of important product safety information         
• Works with CSPV senior management to create and align processes that address global CSPV objectives.  Represent CSPV in cross-functional meetings (e.g. Safety Management Team) and engages with colleagues in Medical affairs, Regulatory Affairs, Quality etc.
• Contribution to maintenance of Pharmacovigilance Quality Management System including creation and maintenance of Standard Operating Procedures (SOPs) within Clinical Safety & Pharmacovigilance department     

Requirements:

• University Degree in Medical Science with at least 8 years of work experience
• Experience in summarizing and presenting safety data
• Strong communication skills
• Experience in project management and working in a matrix environment
• International, European and PV laws
• Fluent business English (oral and written)

What we offer

Working at Daiichi Sankyo

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.