Clinical Safety Specialist

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 multi-task. Ability to assimilate and analyse information rapidly.
• High sense of responsibility and self-motivation
• Highly service-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 pharmacy-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 pre-authorisation area.