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:

• Documents details of potential adverse events which do not meet criteria for entry into database.
• Compiles and organizes information obtained from health professionals and consumers regarding possible adverse events.
• Reviews regulatory reporting requirements and prepares preliminary assessment of seriousness, causality and expectedness/listed Ness in accordance with regulatory guidelines and product labeling. Inputs codes for adverse events to appropriate database.
• Organizes data and narratives regarding adverse events, particularly short and long-term effects, involving clinical study or post marketing drugs and products.
• Gathers and arranges cumulative safety data for submission to regulatory agencies.
• 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.

Required:

• Effective written and oral communication skills in English and French.
• Generally, Requires 2-4 Years
• University/bachelor's degree or Equivalent.

Skills needed:

• Health Care Professional
• PV experience
• Bilingual in English and French (oral and written)