Assoc Medical Mgr PSS / PV REMOTE based in Canada
Top Benefits
About the role
Job Description Fortrea is currently seeking an Associate Medical Manager - MD / DO (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 …
- MD or DO with at least 4 years of pharmacovigilance experience (clinical trial and post approval experience)
- Comprehensive understanding of US healthcare system
- 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 Need To Bring
- MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years of experience with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and risk management.
- Strong understanding of regulatory requirements relating to Pharmacovigilance.
- At least 4 years pharmaceutical industry experience, including and specific to pharmacovigilance (post approval experience, case processing, medical review) and/or clinical research.
- 1 to 2 years of clinical practice experience.
Learn more about our EEO & Accommodations request here.
About Fortrea
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network.
Our talented and diverse team of approximately 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
Assoc Medical Mgr PSS / PV REMOTE based in Canada
Top Benefits
About the role
Job Description Fortrea is currently seeking an Associate Medical Manager - MD / DO (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 …
- MD or DO with at least 4 years of pharmacovigilance experience (clinical trial and post approval experience)
- Comprehensive understanding of US healthcare system
- 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 Need To Bring
- MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years of experience with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and risk management.
- Strong understanding of regulatory requirements relating to Pharmacovigilance.
- At least 4 years pharmaceutical industry experience, including and specific to pharmacovigilance (post approval experience, case processing, medical review) and/or clinical research.
- 1 to 2 years of clinical practice experience.
Learn more about our EEO & Accommodations request here.
About Fortrea
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network.
Our talented and diverse team of approximately 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.