Course “CMC Management in Regulatory Affairs – Quality data for marketing authorisation in Europe”

Are you a CMC manager, regulatory affairs manager or a manager of the quality assurance department dealing with the compilation and the maintenance of the Module 3 of the CTD, classification of quality-related changes?

FORUM • Institut für Management organizes the course “CMC Management in Regulatory Affairs – Quality data for marketing authorisation in Europe”, 5 and 6 November 2018 in Amsterdam. This training course will give you in-depth knowledge of CMC requirements for marketing authorisation. The experts will address essential quality data and provide strategic information on CMC writing and maintenance.

Are you interested? Click on the page below for more info:

Course “Marketing authorisation in Europe for beginners”

Are you working in regulatory affairs or in related departments that need essential European regulatory affairs expertise? Do you need essential European regulatory affairs knowledge?

FORUM • Institut für Management organizes the course “Marketing authorisation in Europe for beginners”
(19-21 November 2018 in Amsterdam)
will inform you about all the important obligations and challenges in regulatory affairs.

You will learn about the different procedures in Europe and about the data and documents required for successful marketing authorisations. Moreover, you will gain practical knowledge about the regulatory life cycle management for a product and the structure and submission of an electronic dossier. Basic pharmaceutical knowledge is recommended but not prerequisite.

Are you interested? Click on the page below for more info:

CLOSED – Vacancy: Medical Safety Physician Consultant 32 – 40 hrs per week

DADA CONSULTANCY B.V. (, is a leading, independent and international consultancy in the field of development, registration and quality control of medicines (human and veterinary). DADA is located in a modern office building in Nijmegen and Poland. You will work in a young and enthusiastic team of 26 employees.

DADA is characterized by its high quality of service and by an open and informal atmosphere at the office.
We are looking to strengthen our pharmacovigilance department with a:

Medical Safety Physician Consultant

(32 – 40 hrs per week)

You start the day between 08:00 and 09:00. After your first cup of coffee, scan your mailbox if there are urgent matters. One of your tasks is to actively manage and evaluate the risks associated with allocated medicines. Together with the QPPV you ensure:

  • Coordination and execution of the medical analysis of adverse reaction reports and / or signal detection activities for assigned products in clinical development and after authorization;
  • Providing medical input to the Clinical Team with regard to safety aspects of the design and preparation of protocols, research brochures, research letters and reports, for the follow-up and processing of clinical research safety data and conduct the safety analyzes of the assigned projects.

What are you going to do, among other things?

  • Perform medical review and provide medical advice on safety-related aspects associated with the assigned products;
  • Perform signal detection and evaluation of safety for assigned products;
  • Provide appropriate and timely Benefit Risk Assessments and safety related regulatory reports for assigned products (e.g. writing PSURs, PADER, DSUR);
  • Design, track and follow up risk management plans for the products assigned and assure their sound implementation;
  • Provide medical-related support during pharmaceutical development and registration/variation procedures;
  • Provide medical guidance for conducting Health and Safety Assessments;
  • Conducting medical review and monitoring safety data from clinical trials;
  • Writing scientific advice or response documents to health authority’s clinical questions/remarks;
  • Develop and conduct pharmacovigilance and product training;
  • Answer and follow-up queries from consumers, patients, and health care professionals;
  • Implement applicable PV regulations for the assigned products;
  • Implement and follow-up of safety data exchange agreements for products assigned.

This is you:

  • You have a medical degree;
  • You master the English language and it is a plus if you also speak Dutch;
  • You have good communication skills;
  • Drug safety evaluation and risk management knowledge and experience is preferred;
  • Understanding of the Dutch Healthcare System (and other systems in EU) would be excellent;
  • GCP certification is a plus;
  • Time management is not a problem for you! You are perfectly capable of setting your own planning and priorities;
  • You work accurately and you have a compliance mind-set to perform according to procedures;
  • You like to work in a team;
  • You are stress resistant;
  • You are open to (proposing) change;
  • You want to learn something every day.

What can you expect from us?

An interesting, varied and dynamic work environment with excellent primary and secondary employment conditions. Where necessary, you are trained internally or externally.

Are you interested?

We would like to receive your CV and motivation letter in English.

DADA Consultancy BV
T.a.v. Patty Robins (Human Resources)
Godfried Bomansstraat 31
6543 JA Nijmegen

Or send an e-mail to

Please do not contact us if you are a recruitment agency.


DADA is now compliant with ISO 9001:2015

“We are pleased to announce that our quality management system is now compliant with the ISO 9001:2015 standard. We are now (re)certified by TUV.”