Safety Physician (m/f/x)  - Director Oncology (ADC)

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Date: 27-Jul-2022

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

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 Clinical Safety & Pharmacovigilance department in our European headquarters in Munich we are seeking highly qualified candidates to fill the position:

 

Safety Physician (m/f/x)  - Director Oncology (ADC) 


Key responsibilities:

  • Serve as an Oncology Product Safety Lead Physician for EU submissions (new and/or supplemental indication) and EU post-marketing activities with assigned oncology products marketed/under development (e.g. Antibody Drug Conjugation [ADC] portfolio)

  • Drives the safety strategy for the lifecycle management of assigned product(s)

  • Safety surveillance and risk management activities for assigned product portfolio (e.g. Oversees the development, maintenance and submission of relevant RMPs, PSURs for designated products.  Responsible for the safety content of other relevant safety documents (e.g. SmPC, Signal detection reports) 

  • Performs signal management activities including safety communication and mitigation using available internal and external post-marketing data

  • Provides medical-scientific analysis of clinical trials, Post Authorisation Safety Studies (PASS) and non-interventional studies (NIS). Performs final comprehensive assessment and interpretation of safety data

  • 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 

  • Effectively interfaces with key safety stakeholders from HQs in US and Japan to align with global product strategy

  • 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.

  • Adheres to associated SOPs and regulatory guidance. Contribution to maintenance of Pharmacovigilance Quality Management System including creation and maintenance of Standard Operating Procedures (SOPs) within Clinical Safety & Pharmacovigilance department

  • Leads a group of safety physicians/safety scientists. Recruits direct reports, trains and develops them using individual development plans and routine day-to-day manager/employee interactions


Professional experience and personal skills:

  • Prerequisite for this position is a successfully completed education as a physician, as well as an approbation as physician

  • Professional experience of at least five years in a similar position within the pharmaceutical industry

  • Oncology product experience is needed

  • Work experience with global teams (e.g. US, Japan) is preferred

  • Experience managing people preferred

  • Fluent English in written and spoken

 

We are looking for a flexible, stress-resistant team player who can work reliably also under time pressure. Your thinking is analytical and structured; your work style shows a high level of responsibility and quality consciousness. If you in addition like to work in a multi-cultural and international cooperation, then you are the right person for us.


 

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.