Drug Safety Scientist (m/f/x)

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Date: 06-Aug-2019

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 13 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:

 

 

Drug Safety Scientist (m/f/x)

 

Key responsibilities:

 

  • Supports preparation of submission documents for marketing authorization applications (MAA) for oncology products requested by European authorities
  • Supports the generation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs) and Signal Detection Reports
  • Supports oncology group in assessing the medical risk of oncology product complaints and to initiate the necessary actions if needed
  • Supports in creating, proposing and implementing risk mitigation actions for a new oncology product
  • Performs triage of incoming cases of Individual Case Safety Reports (ICSRs) and clinical trial serious adverse events
  • Review of study synopses/protocols, investigators brochures, study reports and regulatory documents
  • Contribution and support of Regulatory Affairs department concerning creation of regulatory documents

 

Professional experience and personal skills:

 

  • Graduate degree in Health Sciences (PharmD, PhD), molecular biology, biochemistry, pharmacy or equivalent educational background combined with professional experience in pharmacovigilance and clinical safety
  • 2-3 years working experience in Drug Safety including experience in post marketing surveillance / drug safety operations
  • Detailed knowledge of the use of drug safety databases, individual case processing experience and practical expertise with MedDRA
  • Thorough understanding of ICH-GCP, cGMP, EMA Guidelines and European Regulations and Directives, and other national regulatory requirements pertaining to adverse event assessment and reporting
  • Able to interpret safety data and to write safety texts for MAA dossiers
  • Personal integrity and high degree of confidentiality
  • Ability to handle and prioritize multiple complex projects and tasks simultaneously and to work independently
  • 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.