Assoc Medical Mgr PSS / PV REMOTE based in Canada

Fortrea; Toronto; Remote; CAD 100,000 - 130,000; Full time

Job summary

A leading life sciences company is seeking an Associate Medical Manager - MD / DO (Patient Safety Solutions) to work remotely in Canada. The role requires expertise in pharmacovigilance with at least 4 years of experience. Responsibilities include conducting medical reviews, updating case data, and training team members. Candidates must have a comprehensive understanding of the US healthcare system and relevant regulatory requirements.

Qualifications

• At least 4 years of pharmacovigilance experience (clinical trial and post approval).
• Proficient in English (speaking, writing, reading).
• Knowledge of regulatory requirements for Clinical Research.

Responsibilities

• Conduct medical review of cases including assessment of seriousness.
• Update daily case data and document feedback.
• Provide training to the case processing team on medical aspects.

Skills

Pharmacovigilance experience

Understanding of US healthcare system

Medical sciences knowledge

Regulatory requirements understanding

ICH-GCP guidelines knowledge

Education

MD or DO degree

Job description

Overview

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.

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.

Required Experience : Manager

Key Skills

Anti Money Laundering,Access Control,Content Development,Flex,AC Maintenance,Application Programming

Employment Type : Full-Time

Experience : years

Vacancy : 1