Job Description
With over 120 years of experience and more than 17,000 employees in over 20 countries, 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 strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
We are seeking a highly qualified candidate to fill the position:
(Senior) Director Safety Physician - ADC (m/f/x)
- Responsible for the overarching, global safety strategy and risk management activities, across the lifecycle, for assigned oncology product (i.e. Antibody Drug Conjugation [ADC] oncology portfolio).
- Main focus is safety monitoring and risk management for post-marketing phase in accordance with applicable regulations.
- Collaborates with Global and EU Product Safety Leads and, effectively interfaces with key high-level internal and external stakeholders, takes a lead for regulatory reports (such as RMPs and periodic reports) and drives proactive implementation of risk management initiatives in accordance with global and EU regulatory requirements.
Roles & Responsibilities:
- Engage and provide strategic input on post-marketing safety surveillance with global safety team for oncology products.
- Drive the safety strategy for the lifecycle management of designated product(s).
- Lead the development, maintenance and submission of relevant RMPs, PSURs for designated product(s).
- Engage in signal detection/management and safety analysis activities in post-marketing phase.
- Engage in EU marketing authorization applications (MAA) activities and ensure the implementation of robust risk management activities.
- Oversee the effectiveness of overall risk management activities.
- Medical-scientific support of clinical trials, Post Authorisation Safety Studies (PASS) and non-interventional studies (NIS) concerning pharmacovigilance aspects
- Manage regulatory responses to emerging safety issues and provides strategies to address these in collaboration with global safety team.
- Work with Clincial Safety and Pharmacovigilance (CSPV) senior management to create and align processes that address global CSPV objectives.
- Contribute to maintenance of Pharmacovigilance Quality Management System including creation and maintenance of Standard Operating Procedures (SOPs) within Clinical Safety & Pharmacovigilance (CSPV) department.
- Education and experience
- Completed study of human medicines (MD)
- Work experience (hospital, university, CRO etc.) of at least 5 years
- Experience in the field of pharmacovigilance of at least 3 years
- Knowledge of the international legislation as well as the guidelines concerning pharmacovigilance
- Good or excellent computer skills and good or excellent knowledge of English
- Competencies and generic skills
- High reliability and accuracy and strong communication skills
- Analytic and systematic approach
- Ability to understand complex matters and well-educated risk taking
- Good interpersonal and negotiation skills
- Ability to assert oneself, ability to motivate personnel
- Good problem-solving skills, respect and appreciation for cultural diversity
- Team player, good communication skills, in particular also on intercultural level
- Excellent Benefits
- Work-Life Balance
- Growth and Developement
- Health and Wellbeing Support