Remote Medical Job: Medical Safety Director Job at Parexel in Canada
If you are a doctor looking for a medical job beyond traditional clinical practice, this opportunity could be ideal. Parexel is hiring a Medical Safety Director for experienced physicians interested in pharmacovigilance and patient safety. This role allows doctors to work remotely while contributing to drug safety monitoring, clinical trials, and global healthcare innovation. For professionals exploring remote jobs for doctors or work from home medical jobs, this position offers a unique opportunity to build a career in global drug safety and medical sciences.
Job Details:
- Job Position: Medical Safety Director
- Location: Canada (Remote)
- Additional Remote Locations: Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Saskatchewan, Yukon
- Job ID: R0000038913
- Category: Medical Sciences
About the Company:
Parexel is a global clinical research organization (CRO) that supports the development of innovative medical treatments and therapies. The company works with pharmaceutical, biotechnology, and medical device organizations to accelerate drug development and improve patient outcomes.
Parexel specializes in clinical research, regulatory consulting, pharmacovigilance, and medical affairs. With operations across multiple countries, the company offers professionals opportunities to work on global healthcare projects. Many Parexel jobs provide flexible work models, including remote opportunities, making it an attractive workplace for physicians seeking non-clinical career paths.
Job Description:
The Medical Safety Director Job is a senior-level medical job responsible for ensuring patient safety during clinical trials and post-marketing surveillance. The role involves medical review of safety cases, pharmacovigilance monitoring, regulatory reporting, and collaboration with cross-functional teams.
The Medical Safety Director will act as the medical authority for safety profiles of assigned products while supporting pharmacovigilance activities, safety signal detection, and regulatory documentation.
This position also involves mentoring junior physicians and contributing to safety evaluation strategies for pharmaceutical products. It is an excellent opportunity for doctors exploring remote jobs for doctors and work from home medical jobs in the pharmaceutical and clinical research sector.
Qualifications:
- MBBS / MD or equivalent medical qualification from a recognized medical school
- Completion of clinical training such as residency or internship
- US Board Certification / Board Eligibility or regional equivalent for Canada
- 3 – 5 years of experience in pharmacovigilance or medical monitoring
- Experience in drug safety, patient safety, or clinical practice
- Strong understanding of medical terminology and pharmacovigilance processes
- Knowledge of international regulations including ICH GCP and GVP
- Experience mentoring junior team members
- Strong communication and presentation skills
Key Responsibilities:
General Responsibilities
- Maintain strong knowledge of the adverse event and safety profile of assigned products.
- Ensure compliance with global drug safety regulations and reporting timelines.
- Communicate safety review issues with project leaders, managers, and internal stakeholders.
- Participate in cross-functional meetings and provide pharmacovigilance expertise.
- Assist in audits, inspections, and process improvement initiatives.
- Work closely with project teams to meet performance indicators and safety requirements.
Case Review and Pharmacovigilance Activities
- Conduct medical review of complex safety cases from clinical trials and literature sources.
- Assess causality and provide pharmacovigilance comments for regulatory reporting.
- Evaluate seriousness, listedness, and expectedness of reported adverse events.
- Review narrative content for medical coherence and accuracy.
- Provide guidance to case processing teams and junior physicians.
- Identify case issues and coordinate with therapeutic and legal teams.
Periodic Safety Reports
- Review and author aggregate safety reports for regulatory submission.
- Provide medical input into documents such as:
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Development Safety Update Reports (DSURs)
- Signal Evaluation Reports (SERs)
- Health Authority response documents
Medical Monitoring
- Provide medical and scientific support to project teams and clinical trial staff.
- Review adverse event reports for clinical relevance and severity.
- Analyze data management listings including laboratory data and medical history.
- Support preparation of clinical protocols, reports, and scientific publications.
Signal Detection and Safety Management
- Perform signal detection and validation activities.
- Conduct medical assessments of safety alerts from data analysis.
- Manage safety signals using project-specific tools and tracking systems.
- Participate in Safety Management Team meetings and regulatory discussions.
Therapeutic Area Expertise
- Serve as a subject matter expert within the designated therapeutic area.
- Support development of pharmacovigilance strategies and risk management plans.
- Mentor junior physicians and provide training on safety methodologies.
- Participate in scientific forums and internal knowledge-sharing activities.
