CLINICAL SAVETY ASSOCIATE

Business & Decision Belgium
Sint Lambertusstraat 141 Rue Saint Lambert
1200 Brussels
Belgium
Phone : +322 774 11 00
Fax : +322 774 11 99
Contact

Job detail

Functional Area:

• Handling of safety cases

Duties and responsibilities:

Tasks may include:

• Triaging, collecting, monitoring, processing, and distributing adverse event reports (serious and non-serious Adverse Event(s) to the sponsor or regulatory authorities and project team within the specified timelines
• Duplication check and book-in of cases, acknowledge receipt
• Code adverse events using the standardized MedDRA dictionary 
• Identification of missing information
• Perform data entry functions required for the safety database
• Provide coverage for serious adverse events reported during non business hours, weekends, and holidays on rotational basis, as required by assigned protocols
• Perform comparative review and reconcile serious adverse events between the Clinical and Safety databases
• Interact with physicians for clarification or missing elements
• Create case files and submit to physician for review
• Aid the project team in the preparation of customized and other regulatory safety reports (i.e. CIOMS, EMEA, BHA, DSMB and Annual Reports)
• Perform other safety-related tasks as necessary

Job requirement

Experience/Skills/Competencies:

• By preference minimum 6 months to 2 years of (relevant) experience
• Good knowledge of pharmacovigilance  process, systems and guidance
• Good knowledge of English (written and spoken)
• Good organization skills

Education:

• Scientific Degree (Bachelor) or equivalent experience
• Bachelor of Nursing , Bachelors Degree with a concentration in the Health Sciences or relevant health care/research experience