Safety Physician Oncology (m/f/x)

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Date: 09-Nov-2018

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

Affiliate: Daiichi Sankyo Europe GmbH

 

Passion for Innovation. Compassion for Patients.™

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, the Group’s 2025 vision is to become a “Global Pharma Innovator with Competitive Advantage in Oncology”. Our European headquarters are in Munich, Germany and we have affiliates in 12 European countries. For more information: www.daiichi-sankyo.eu.

 

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

 

 

Safety Physician Oncology (m/f/x)

 

Key responsibilities:

  • Responsible for safety activities for new oncology products
  • Preparation of submission documents for marketing authorization applications (MAA) for oncology products requested by European authorities
  • Supervision and provision of answers to outstanding authority questions during MAA
  • Performs triage of incoming cases of Individual Case Safety Reports (ICSRs) and clinical trial serious adverse events, generates narratives including medical evaluation and generation of company comment
  • Generates and ensures timely submission of Periodic Safety Update Reports (PSURs) Development Safety Update Reports (DSURs), Risk Management Plans (RMPs) and Signal Detection Reports
  • On-going pharmacovigilance evaluation for medicinal products and creation of response documents for health authority requests
  • Medical-scientific analysis of clinical trials, Post Authorisation Safety Studies (PASS) and non-interventional studies (NIS) concerning pharmacovigilance aspects
  • Creation and maintenance of Standard Operating Procedures (SOPs) within Clinical Safety & Pharmacovigilance department
  • Contribution to maintenance of pharmacovigilance quality management system
  • Review of study synopses/protocols, investigators brochures, study reports and regulatory documents
  • Contribution and support of Regulatory Affairs department concerning creation of regulatory documents
  • Member of global project groups

 

Professional experience and personal skills:

  • Medical degree as well as an approbation as physician
  • Minimum of 2 years of relevant experience in a similar position within the pharmaceutical industry
  • Experience in the oncological field for at least of 2 years
  • Ability to interact target-aimed internally as well as externally to support a global business strategy
  • Very good knowledge of database and coding systems and strong analytical skills
  • Personal integrity and high degree of confidentiality
  • Ability to handle and prioritize multiple complex projects and tasks simultaneously and to work independently
  • Good knowledge of MS Office
  • Fluent in English and German, both in oral and written communication

 

 

What we offer:

 

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.