Clinical Safety Specialist Lisboa

Clinical Safety Specialist
Lisboa
Lisboa, Lisboa, Portugal

We have an exciting opportunity for a PV Specialist to join our Clinical Safety team! This role can be based remotely in Spain and we are, above all else, looking for an individual who is motivated and enthusiastic to grow with our Pharmalex brand which has seen great success. Management of SAEs/AESIs/pregnancies
Assure all parties are informed as required & querying the sites when needed; follow the whole process for each case/remind parties of pending information when applicable. Initial triage (assessment of expectedness/seriousness) of SAEs. Data Entry in safety database
Narrative writing
Support Safety Manager with Review of cases in safety database (QC)Preparation of Line Listings
Maintaining annual plans for LLs / DSURs and distribution lists. Safety submissions. Maintenance of trackers and other administrative activities. Skills
Team-oriented approach
Organizational skills, ability to
- task. Ability to assimilate and analyse information rapidly. High sense of responsibility and
- motivation
Highly
- oriented
Flexibility and adaptability to adjust rapidly to new, unknown, challenging situations. Fluent written and spoken English skills. Excellent written and verbal communication skills. Experience/Background
Successful completion of a Bachelor’s degree in medical, natural sciences or
- related field or Degree in Medicine
At least 1 year of relevant professional experience in the field of Pharmacovigilance. Knowledge of safety databases (Argus, Safety Easy are preferred)Experience in case management activities
Previous experience in
- authorisation area.