DADA CONSULTANCY B.V. (www.dada.nl), is a leading, independent and international consultancy in the field of development, registration and pharmacovigilance of medicines (human and veterinary). DADA is located in a modern office building in Nijmegen (The Netherlands) and Gdańsk (Poland) with 36 employees in total.
DADA is a young and fast-growing company characterized by its high quality of service and by an open and informal atmosphere at the office. You will work in a dynamic and enthusiastic team of 16 employees.
We are looking to strengthen the Benefit Risk Management team of the Pharmacovigilance department with a:
Consultant Medical Safety Physician
(32 – 40 hrs per week)
What are you going to do?
You will be working in the Benefit Risk Management team of the Pharmacovigilance department.
As Consultant Medical Safety Physician, you are responsible for
- Performing medical review and providing medical advice on safety-related aspects associated with the assigned products;
- Performing signal detection and evaluation of safety for assigned products;
- Providing appropriate and timely Benefit Risk Assessments and safety related regulatory reports for assigned products (e.g. writing PSURs, PADERs, DSURs);
- 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;
- 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 and clinical trial regulations for the assigned products;
- Implement and follow-up of safety data exchange agreements for products assigned;
- 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 PV 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 medical review of and safety analyses for the assigned projects.
- You have a medical degree, preferably with relevant working experience in Pharmacovigilance;
- You master the English language in speech and writing 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 and will take the initiative when necessary;
- You continue to develop by, among other things, actively learning from work experiences;
What can you expect from us?
An interesting, varied and dynamic work environment with nice colleagues. Of course, DADA will offer you excellent primary and secondary employment conditions. We also offer you development and growth opportunities within our organization.
Are you interested? We would like to receive your CV and motivation letter in English.
DADA Consultancy BV
T.a.v. Steffie Dirks, Allround Staff Assistant
Godfried Bomansstraat 31
6543 JA Nijmegen
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