Consultant Medical Safety Physician

• 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, PADERs, DSURs)
• Designing, tracking and following up risk management plans for the assigned products and assuring their sound implementation
• Providing medical-related support during pharmaceutical development and registration/variation procedures
• Providing 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 authorities' clinical questions/remarks
• Developing and conducting pharmacovigilance and product training
• Answering and following up queries from consumers, patients and healthcare professionals
• Implementing applicable PV regulations for the assigned products
• Contributing to the pharmacovigilance system in place at the DADA Pharmacovigilance department
• Providing medical input to the PV team on safety aspects of the design and preparation of protocols, Investigator's Brochures, research letters and reports and safety management plans, for the follow-up and processing of clinical research safety data, and conducting the safety analyses of the assigned projects

• You have a medical degree, preferably with relevant working experience in pharmacovigilance
• You master the English language in speech and writing; 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 of 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 have a compliance mindset to perform according to procedures
• You like to work in a team
• You are stress resistant
• You are open to (proposing) change and take initiative when necessary
• You continue to develop by, among other things, actively learning from work experiences

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 organisation.