Senior Clinical Safety Specialist

4 days ago


Greater Toronto Area, Canada Brunel Full time
About the Role

We are seeking a highly experienced Senior Clinical Safety Specialist to join our team at Brunel. As a global pharmaceutical company, we are dedicated to delivering innovative technology and products in nutrition, diagnostics, medical devices, and branded generic pharmaceuticals.

This role will involve leading the clinical safety strategy for assigned drug projects and products across all stages of development and post-marketing. Your focus will be on ensuring the ongoing assessment, evaluation, and risk management of the products to maintain safe profiles.

Key Responsibilities
  • Develop and implement clinical safety strategies, including risk identification, mitigation, and benefit-risk assessment.
  • Review and endorse risk management plans and safety specifications.
  • Provide strategic safety input for clinical development and regulatory submissions.
  • Collaborate with cross-functional teams to ensure safety measures are integrated into key project documents.
  • Represent patient safety in meetings and provide medical input for safety-related issues.
  • Conduct safety surveillance, signal detection, and risk evaluations.
  • Provide medical expertise for safety data assessments and regulatory documentation for label updates.
  • Collaborate on signal management and communicate findings to relevant stakeholders.
  • Contribute to periodic safety reports and regulatory submissions for new products or indications.
Requirements
  • Medical degree (e.g., MD, MBBS)
  • At least 5 years of experience with clinical drug safety and pharmacovigilance; including safety strategy for drug products in clinical development within the pharmaceutical industry.
  • Experience across therapeutic areas and functions, including team supervision
  • Familiarity with epidemiological data analysis.
About Us

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

Salary Range

The estimated salary range for this position is $120,000 - $180,000 per year, depending on experience and qualifications.



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