Safety / Project Physician [Pharmacovigilance]

United BioSource; Canada; Remote; CAD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking company dedicated to improving patient outcomes and advancing healthcare. In this role, you'll provide vital medical support within the Safety Department, ensuring compliance with project and regulatory timelines. You'll engage in critical tasks such as reviewing adverse event reports, conducting signal detection, and preparing safety reports. This innovative firm values collaboration and inclusivity, offering a flexible work environment and opportunities for professional growth. If you're looking to make a meaningful impact in the pharmaceutical industry, this position is perfect for you.

Benefits

Remote Opportunities

Growth Opportunities for Promotion

401K with Company Match

Tuition Reimbursement

Flexible Work Environment

Discretionary PTO

Paid Holidays

Employee Assistance Programs

Medical, Dental, and Vision Coverage

Wellness Program

Qualifications

• At least 2 years of clinical practice experience.
• Knowledge of relevant regulations and legislation.

Responsibilities

• Support the Safety Manager and ensure project timelines are met.
• Perform medical review of individual cases and safety reports.
• Participate in training and mentoring of new hires.

Skills

Clinical Practice Experience

Drug Safety Knowledge

Communication Skills

Interpersonal Skills

Presentation Skills

Regulatory Knowledge

Education

MD or DO License

Clinical Research Experience

Job description

As a pharmaceutical support industry leader , UBC is devoted to empowering health solutions for a better tomorrow . We take pride in improving patient outcomes and advancing healthcare. At UBCwe provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being : Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

Brief Description :

This position is primarily responsible for providing medical support to all operational functions within the Safety Department.

Specific job duties :

• Support the Safety Manager, the Associate Director, Safety and the Executive Director / Director, Safety.
• Organize the workflow for a given task or project.
• Ensure that given timelines are met according to project and regulatory timelines.
• Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs) : write / review the narrative, perform seriousness rating and causality assessment.
• Perform medical review of individual cases or safety reports.
• Perform ICSR signal / trend detection.
• Perform Aggregate line listing signal / trend detection.
• Evaluate laboratory values for potential SAEs.
• Review SAE and AE coding to ensure medical accuracy with the verbatim reported term.
• Participate in Quality Check activities.
• Ensures medical and scientific input in study protocols and reports.
• Issue medical follow-up queries and contact reporters if necessary.
• Prepare internal SOPs and project specific procedures.
• Write / participate in writing safety reports (RMPs, PSURs, ARs, SBRs, Issue workups, annual reports…).
• Keep up to date about the relevant regulations, legislation and literature of Pharmacovigilance, pharmacology and pharmacoepidemiology.
• Participate in relevant seminars and congresses (if requested).
• Participate in training and mentoring of new hires with UBC safety processes.
• Other duties as assigned by management.

Desired Skills and Qualifications :

• MD, DO license preferred, but not required
• At least 2 years clinical practice experience
• Experience in drug safety in Pharma, biotech or CRO
• Some direct clinical research experience is preferred
• Knowledge of relevant regulation and legislation
• Fluent in English; additional languages a plus, but not required
• Excellent written and verbal communication skills
• Good interpersonal skills
• Excellent presentation skills

Benefits :

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers :

• Remote opportunities
• Growth opportunities for promotion
• 401K with company match
• Tuition reimbursement (after 90 days of employment)
• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA / FSA
• Wellness program
• Adoption assistance
• Short term disability (after 90 days of employment)