Clinical Safety Senior Specialist

PharmaLex

Lisbon, Portugal

há 2 dias

Your Job

Provide support to CSL and act as their back-up during holidays.

Oversight of activities performed by Junior specialists Training safety specialists / Overview of SAE process handled by junior specialists.

Support Safety Manager with Review of cases in safety database (QC)

DSUR support with some sections and DSUR submission

SUSAR management SUSAR submissionMaintaining SUSAR trackers for every projectMaintaining LL trackers for every project

Maintaining annual plans for LLs / DSURs and distribution lists.

Monthly updates on local requirements from Regulatory Authorities / Ethic Committees

Your Profile

Successful completion of a Bachelor’s degree in medical, natural sciences or pharmacy-related field or Degree in Medicine

Good knowledge of clinical trial PV legislation (at least in EU) and in Good Clinical Practices

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 activitiesPrevious experience in pre-authorisation area.

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.

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