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Director Clinical Safety
hace 1 mes
Social network you want to login/join with:
Director Clinical Safety (m/f/x), GironaClient:Location:Job Category:Other
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EU work permit required:Yes
Job Views:4
Posted:06.03.2025
Expiry Date:20.04.2025
Job Description:Passion for Innovation.
Compassion for Patients. 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 looking for a Director Clinical Safety (m/f/x).
The position:The Director, Clinical Safety, will be a product safety lead or part of a product safety team, responsible for overall product safety strategy or specific areas of safety surveillance and risk management.
This individual will provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions.
This role ensures proactive safety monitoring and risk management through the Safety Management Team framework and requires strong leadership and communication skills for effective collaboration across development functions and sites.
The individual may function as a key member of the Global Product Team, collaborating with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug.
Responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).
Depending on the status of development of the compound, this role leads and medically directs a team of junior physicians and scientists responsible for a compound/product safety, including project-specific training and coaching of team members and review of team output cross-functionally.
Responsibilities include reviewing and analyzing data from clinical trials, post-marketing, and other relevant sources for the prompt identification of safety signals, and evaluating serious adverse event reports for completeness, accuracy, expectedness, and relatedness.
Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.
Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.
Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time, and coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).
Work with CSPV senior management to create and align processes that address global CSPV objectives.
Professional experience & education:Prerequisite for this position is a successfully completed education as a physician, as well as an approbation as a physician.
Professional experience of at least four years in a similar position in the pharmaceutical industry, regulatory agency, or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology is required.
Oncology product experience is preferred, as is work experience with global teams (e.g., US, Japan).
Fluency in English, both written and spoken, is essential.
We are looking for a flexible, stress-resistant team player who can work reliably under time pressure.
The ideal candidate will have analytical and structured thinking, with a high level of responsibility and quality consciousness.
If you enjoy working in a multi-cultural and international environment, we would like to hear from you.
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.
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