Associate Director, Pharmacovigilance

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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 UBC, we 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 as a Associate Director Pharmacovigilance! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Collaboration, Conscientiousness, Curiosity, Compassion and Consultation. 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!

As an Associate Director Pharmacovigilance you will be responsible for execution of global Pharmacovigilance (PV) case processing activities contracted by UBC’s clients. Responsible for deliverables which ensure regulatory compliance, data quality, and team productivity. 

Specific Job Duties:

• Responsible for ensuring global regulatory reporting compliance by execution of processes and compliance with procedures for processing adverse experience reports originating from clinical studies, literature, and the marketplace for client specific products. 
• Ensures the timely completion and distribution of adverse experience reports to Health Authorities, distributors, client partners, and clients.
• Ensures timely identification of Individual Single Case reports and / or relevant safety information during the monitoring of the literature.
• Evaluates and determines appropriate PV resources to assign to project teams as requested for proposals and project execution.
• Evaluates staffing requirements and adjust accordingly
• Operationalizes client specific projects relating to PV to ensure a quality management system.
• Ensures understanding by Team of project specific requirements and document required procedures and metrics.
• Ensures preparation of relevant project specific plans linked to case processing and literature activities. 
• Participate in preparation or review of relevant UBC PV Standard Operating Procedures (SOPs), Working Practices (WPs), trainings and other standard material required for PV staff.
• Is responsible for appropriate documentation of non-compliance with client’s regulatory requirements in Safety Incident Reports (SIRs), Problem Notification Forms and Corrective and Preventive Actions (CAPA) as required.
• Ensures the provision of the business requirements to the team responsible for UBC Argus implementation and maintenance. 
• Approves case deactivation requests as per procedure.
• Responsible for the training and mentoring of PV staff on new/existing regulations, processes, assigned project(s), client interactions and other areas as needed.
• Provides update / progress reports to Leadership.
• Conducts regular meetings with his/her direct PV reports.
• Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations.
• Attends client operational Face to Face meetings, Investigator meetings and teleconferences as needed.
• Evaluates and responds to client requests for proposals as needed. Participates in bid-defense preparation and attendance as needed.
• Attends and supports client audits and regulatory inspections from a pharmacovigilance operations standpoint. 
• Ensures completion of employee performance objectives and development plans.  Conduct annual employee performance evaluations.
• Performs additional duties as assigned by UBC Management.

Supervisory Responsibilities:

Supervision of global pharmacovigilance staff (n= 4-6 direct reports) and 20-40 indirect reports.

Desired Skills and Qualifications:

• Bachelor's Degree in a science or health-related field, pharmacy or nursing required.   
• Minimum of 8 years of experience in a pharmaceutical company or a service provider (e.g., CRO).
• Minimum 4 years of experience at increasing levels of responsibility in PV with case processing team management responsibilities. 
• Advanced knowledge of global and local PV regulations and legislation, both pre- and post-marketing required.
• PV reporting experience should include drugs and biologics. Experience with safety surveillance of vaccines and medical devices a plus but not required.
• Strong leadership, analytical, and organizational skills required. 
• Strong written and verbal communication skills.
• Strong presentation skills.
• Strong interpersonal skills. 
• Must be able to speak fluent English.
• Proficient with computer programs (WORD, PowerPoint, excel)
• Experience in processing safety data within Argus required. Experience with other PV databases (e.g., ARISg) a plus but not required.
• Ability to manage PV staff and work effectively as a Team. 
• Ability to manage multiple client projects simultaneously.
• Ability to travel from time to time to UBC locations, clients, and professional/scientific meetings.

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
• Flexible work environment
• Discretionary PTO (Paid Time Off) OR 20 days (about 3 weeks) of PTO
• Paid Holidays
• Employee assistance programs 
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability
• 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.

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