Drug Safety Physician

PUB322982

Bioltechnologist inserting in pipet in lab

About this role: Drug Safety Physician

About this role: Drug Safety Physician

We’re hiring a Drug Safety Physician for our client, a large international organization focusing on research development, production, and commercialization of innovative therapeutic solutions. This a one-year contract opportunity covering a maternity leave. The ideal candidate would be in Canada and would be able to work remotely. The purpose of the Drug Safety Physician is to act as a Medical Reviewer and safety expert for projects and studies conducted within the organizations Rare Disease unit.

  • Provides medical input to clinical teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, and reports
  • Supports and reviews safety data in clinical trials, study protocols, statistical analysis plans and other clinical study-related documents
  • Reviews of AEs/SAEs from clinical trials as needed
  • Participates in study team meetings as requested or needed
  • Assists in preparation and if required, presents Medical Safety’s recommendations on safety issues to the cross-functional decision-making body
  • In collaboration with Global Pharmacovigilance, works on development of risk management strategy and activities for products in clinical development
  • Supports activities related to new drug applications and other regulatory findings
  • Coordinates and perform the medical analysis of adverse event reports and/or signal detection activities for assigned projects in clinical development and post-licensure (if needed)
  • Assists in creation, maintenance, and implementation of (D)CSI (Development, Core Safety Information) for the assigned projects.

What you need to bring:

What you need to bring:

  • MD required.
  • 5+ years clinical research experience.
  • In depth understanding of relevant safety and pharmacovigilance guidelines as well as relevant clinical trials regulations.
  • Ability to make independent clinical assessments and decisions, based on professional and scientific responsibilities to patients, prescribers, regulators, and providers.
  • Ability to analyze large datasets and lead multidisciplinary teams to provide accurate and robust assessments of such safety-related data.
  • Demonstrated ability with computer software packages (Microsoft Office applications, Internet, Adobe Acrobat Exchange and Safety Database software)
  • Strong interpersonal and verbal/written communication skills.
  • Demonstrated effective organizational and time management skills. Ability to manage multiple priorities in an efficient manner under pressure.
  • Proven ability in implementation of new initiatives and receptive to change in demands and workload.
  • Ability to establish and maintain effective working relationships with coworkers, management and customers.
  • Experience with safety databases (ARGUS preferred).
  • Experience with medical terminology (e.g., MedDRA and WHODRUG).

Benefits:

Benefits:

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

Anything Else?

Anything Else?

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

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Chris Kapusta is happy to clarify anything about this vacancy. When reaching out, use this number:
PUB322982

Account manager

Chris Kapusta
Brunel Canada - Calgary
c.kapusta@brunel.net

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