Associate Medical Manager, PSS - REMOTE based in Canada

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Fortrea is currently seeking an Associate Medical Manager (Patient Safety Solutions), to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment.

This is a full-time, home-based position in Canada

What You Will Do

You will provide medical safety expertise, directly and indirectly, to sponsor drugs, devices, and combination products in the post marketing world.

Other Key Responsibilities

• Undertake primary medical review of cases, including medical assessment of the case for seriousness, listed/labeling, causality, adverse event coding and narrative review.
• Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management.
• Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.
• Provide training and guidance to the case processing team on medical aspects of case processing.
• Performs secondary medical review (QC role) and retrospective review of cases reviewed (QA role), as required for measuring quality of deliverables, identifying error trends, training needs and areas of improvement.
• Undertake any other duties as required
  
  

YOU NEED TO BRING…

• Bachelor’s degree in medical science or MD or DO or equivalent degree.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language skills: English proficient in speaking, writing, and reading.
• Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures.
• Knowledge and understanding of regulatory requirements for Clinical Research.
• Knowledge and understanding of ICH-GCP guidelines.
  
  

PREFERRED Candidates Will Bring

• Good understanding of regulatory requirements relating to Pharmacovigilance.
• Up to 2 years pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and/or clinical research.
• 1 to 2 years of clinicial practice experience.
  
  

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea Is Proud To Be An Equal Opportunity Employer

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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