Safety/Project Physician [Pharmacovigilance]

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
• Strong computer 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
• Competitive salaries
• 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
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability (after 90 days of employment)
• Long term disability
• Life insurance
• Discount programs

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.  We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.