International Pharma Support
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) with 50 employees in total, spread across Europe.
DADA is a young and fast-growing company characterised 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 23 employees in the Pharmacovigilance department. Due to our international clients, English is the working language for procedures and daily operations.
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?
As Consultant Medical Safety Physician in the Benefit Risk Management team, 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 profiles for assigned products;
- Providing 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 and input into conducting Health and Safety Assessments;
- Conducting medical review and monitoring of 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 to queries from consumers, patients, and health care professionals;
- Implement applicable PV regulations for the assigned products;
- Contribute to the pharmacovigilance system in place at the DADA Pharmacovigilance department;
- Providing medical input to the PV Team with regard to safety aspects of the design and preparation of protocols, Investigator’s Brochures, research letters and reports, safety management plans, for the follow-up and processing of clinical research safety data and conduct the safety analyses of the assigned projects.
Competencies/ Education:
- 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 the EU) would be excellent;
- GCP certification and knowledge about clinical safety management 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 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 kind 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. During the recruitment process, we ask candidates to complete an assignment as part of the selection process.
DADA Consultancy BV
T.a.v. Steffie Dirks, Allround Staff Assistant
Godfried Bomansstraat 31
6543 JA Nijmegen
Or send an e-mail to [email protected]
For our privacy policy we kindly refer you to our website: https://www.dada.nl/privacy-statement-english/
Please do not contact us if you are from a recruitment agency.
Werklocatie: Fysiek
