- Our company is the world’s leading inspection, verification, testing and certification company.
- The company employs over 90 000 people and operates a network of more than 1 000 offices and laboratories around the world.
- Our company carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings to support and consultancy on post marketing registration activities.
- Our company has also expertise in the quality control of pharmaceuticals.
- We would like to inform you that we are currently seeking candidates for the position (m/f) : MEDICAL AFFAIRS ASSOCIATE.
- Serious Adverse Events/Adverse Drugs Reactions (SAEs/ADRs) handling (Clinical Trial and Post Marketing) including review of SAEs/ ADRs, performing regulatory assessments and contacts with reporters in order to have events fully documented
- Submission of safety reports to Health Authorities and Ethics Committees as required per project agreements.
- Maintain an overview the different Health Authority and Ethics Committee safety reporting requirements
- Follow up on guidance documents and legislation related to Pharmacovigilance and share knowledge with the team
- Involved as internal and external contact for medical affairs projects
- Setup of a project plan in agreement with the client requests and budget
- Follow up on timelines and see to it that the different responsibilities and assignments are managed as agreed with the client
- Writing, review and development of Development or Periodic Safety Update reports(DSUR/ PSURs)
- University degree or PhD in life sciences
- Experience is a plus
- Quality minded; Eye for detail and being able to make distinction between main and side issues
- Fluently writing and speaking English
- Very good knowledge of Word
- Respecting budgets and timelines
- Being able to prioritise issues according to importance