Drug Safety Physician

PUB322982

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.

Requirements

Requirements

  • 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.

Join the Brunel Family

Career interview session

Join the Brunel Family

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.

Application process

We carefully review your application and in the coming weeks, you will be notified for an interview session if you are selected. Only shortlisted candidates will be contacted within 7 days.

After being shortlisted, you will be contacted via email or telephone to arrange for a date on your availability for the qualification interview.

During the interview, you will be assessed on your level of experience and skills, work history, availability, and the qualifications the company is seeking for the position.

After successfully making through the phone interview, a face to face interview will be scheduled between the candidate and recruiter. This session can be a more in-depth interview to review your communication and interpersonal skills.

Submission of candidates resume for client’s approval and screening.

Start applying immediately

Start applying immediately

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

  • Certifications (optional)
  • 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 the pub number:
PUB322982

Account manager

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

All fresh vacancies in your mailbox?

Sing up for the Brunel job alert

Look at our privacy statement