Drug Safety Specialist Jobs

MUST be HCP (pharmacist, nurse, dentist, physician) AND bilingual (French/English).

Majority of interview will be in French.

Responsible for all stages of adverse event reporting for clinical study and post-marketing drugs and products. Accountable for collecting data, investigating facts and circumstances and reporting findings to appropriate stakeholders and regulatory agencies. Duties & Responsibilities: Organizes data and narratives regarding adverse events, particularly short and long-term effects, involving clinical study or post marketing drugs and products. Reviews regulatory reporting requirements and prepares preliminary assessment of seriousness, causality and expectedness/listedness in accordance with regulatory guidelines and product labeling. Inputs codes for adverse events to appropriate database. Maintains adverse event files and tracking systems. Assists with the preparation of adverse event reports for submission to regulatory agencies within the appropriate reporting timeframes. Compiles and organizes information obtained from health professionals and consumers regarding possible adverse events. Gathers and arranges cumulative safety data for submission to regulatory agencies. Documents details of potential adverse events which do not meet criteria for entry into database. Work Experience: Generally Requires 2-4 Years Work Experience Education Required: University/Bachelors Degree or Equivalent. Skills required: Effective written and oral communication skills in English and French.

Skills Needed

Health Care Professional

Bilingual in English and French (oral and written)

PV experience