About this job
- Industry: Pharmaceutical
- Area of expertise: Regulatory
- Location: Ontario
What is required?
- Hours per week: 37.5
- Education level: Professional Bachelor
About this role: Bilingual Drug Safety Specialist
We are currently hiring Drug Safety Specialist for our client, a global pharmaceutical company committed to healthcare solutions from prevention to treatment. This is a 10-month contract role.
The Drug Safety Specialist is 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.
- 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
- 2-4 years of work experience with drug safety/ pharmacovigilance
- University/Bachelor’s degree or equivalent
- Effective written and oral communication skills in English and French
- Ability to work individually (independently) as well as on a team
- Meticulous, with strong attention to detail, accuracy, and process adherence
What We Offer
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Join the Brunel Family
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Any questions remaining?
Your consultant, Angelina Brathwaite is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto