CSPV Medical Reviewer (m/f/x)

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, 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 are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

For our CSPV team in Munich we are seeking highly qualified candidates to fill the position 

CSPV Medical Reviewer (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 global Medical Reviewer working within a global team (e.g. US, Japan) with solid medical knowledge in both oncology and speciality medicines therapeutic areas and serves as the subject matter expert for individual case medical review process  - to address questions from other members from DS teams or inspectiors/auditors
Active participation in daily medical review activities. Serves as primary contact among DS CSPV for medical review activities, and contributes to signal detection and safety monitoring activities.
The position works with the respective DS product safety leads, the medical review teams from other sites (DSJ, DSI) for global alignment and with the global case processing team to achieve proactive and continuous improvement. The position reports to the Medical Safety Centre of Excellence Lead DSE and reports functionally into the global Center of Excellence Medical Review Lead.

Roles and Responsibilities:

Medical Review

• Provides expert medical review, assessment and communication of ICSRs in both the investigational and marketed settings.  

• Ensures that ICSR reporting meets all relevant internal timelines.

• Provides medical review and assessment of ICSRs, including evaluation of the case narrative for accuracy, medical logic and completeness and review of coding and expectedness (against relevant reference documents).

• Uses medical knowledge, product knowledge and experience to determine potential causes of reported adverse events.

• Determines or confirms the company causality and authors or oversees the causality statement.  

• As requested by management, participates in safety meetings to enhance medical assessment of adverse events of special interest or complex adverse events. 

• Brings medical input to signal detection activity by performing regular line-listing reviews for all speciality medicine products and provides them to the Product Safety Lead and the EU-QPPV. 

• Creates global guidelines for Medical Review.

• Reviews and evaluates pharmaceutical technical complaints on a regular basis to identify any potential ICSRs.

Literature Review

• Evaluates Social Media Monitoring Outputs on a regular basis for ICSR processing

Centers of Excellence

• Supports Centers of Excellence with medical input for Signal Detection, Risk Management Plans, and additional Risk Minimisation Measures (e.g. educational material).

Personal skills and professional experience:

• University Degree in Medical Science                                                                            
• Minimum 5 years of experience
• Positive attitude 
• Experience in medical review
• Strong communication skills
• Fluent business English (oral and written)

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

For more information: www.daiichi-sankyo.eu