Bilingual Drug Safety Specialist

PUB380741

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

Introduction

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.

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

Requirements

Requirements

  • 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

Benefits

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.

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About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Start applying immediately

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  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
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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:
PUB380741

Account manager

Angelina Brathwaite
Brunel Canada - Toronto
a.brathwaite@brunel.net

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