Quality Control Manager (m/f/x) for Pharmacovigilance

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Date: 27-Dec-2020

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 cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter. For more information: www.daiichi-sankyo.eu.

 

 

For our headquarter in Munich we are seeking highly qualified candidates to fill the position of

 

Quality Control Manager (m/f/x) for Pharmacovigilance

 

Purpose of the function:

This role includes all tasks to ensure the safety and operational standards within the pharmacovigilance department are maintained and fulfilled. It also contains the control of quality tasks within the department and related tasks performed by affiliates, license partners and CROs (all post marketing activities including also tasks during conduct of interventional and non-interventional trials).

 

Roles and Responsibilities:

  • Maintenance of Pharmacovigilance System Master File (PSMF) and related documents. Define, manage, maintain and coordinate procedures continuously improving quality in collaboration with the departmental and global groups (e.g. compliance check expedited reporting, key performance indicators, deviations and CAPA management, revising SOPs)  
  • Supports in creation, revision and maintenance of relevant PV agreements
  • Supporting the department regarding GVP/PV audit and inspection preparation and follow-up of CAPAs (corrective and preventive actions) regarding deviations and findings of inspections / audits (e.g. compliance on case distribution in accordance with legal requirements)

 

Personal skills and professional experience:

  • Thorough knowledge of Pharmacovigilance (at least 5 years), additional skills/experience in other GxP areas are an advantage
  • Master degree in Life Sciences, Pharmacy or Medical Sciences preferred
  • Good or Excellent written and verbal communication skills in English
  • Analytic and systematic approach with good problem solving skills
  • Substantial communication skills, in particular also on intercultural level with respect and appreciation of cultural diversity
     

 

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.

 

Please apply online at our Career Portal. We are looking foward to hearing from you.