Responsible for managing the Global Case Processing Units and overseeing global Pharmacovigilance (PV) staff, and for execution of global case processing activities contracted by UBC’s clients.
Responsible for deliverables which ensure regulatory compliance, data quality, and team productivity.
- Bachelor's Degree in a science or health-related field, pharmacy or nursing required.
- Minimum of 5 years of experience in a pharmaceutical company or a service provider (e.g., CRO).
- Minimum 4 years of experience in PV with case processing responsibilities.
- Good 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.
- Team/staff management experience preferred.
- 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 (MS 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.
Supervision of global pharmacovigilance staff (n= 8-16 direct reports).
Specific Job Duties:
- Is 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 Case Safety Reports and/or relevant safety information during the monitoring of the literature.
- Works in collaboration with Associate Director and/or Directors to evaluate staffing requirements and determine appropriate PV resources to assign to project team.
- Operationalizes client specific projects relating to PV to ensure a quality management system.
- Ensures understanding by the Team of project specific requirements and
- Ensures that required procedures and metrics are in place for projects under his/her responsibility.
- Prepares and reviews relevant project specific plans and procedures linked to case processing and literature activities.
- Organizes the workload for all projects under his/her responsibility.
- Monitors the processes and workflow and implements process improvements for all projects under his/her responsibility.
- Participates 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.
- Provides the business requirements to the team responsible for UBC Argus implementation and maintenance. In conjunction with the Argus team, participates in User Acceptance Testing (UAT), including, but not limited to, coordination, generation, and execution of test scripts.
- Approves Argus case deactivation requests.
- Reviews and approves Argus Output Request, Change Control and User Access Request Forms as appropriate.
- Trains and mentors PV staff on new/existing regulations, processes, assigned project(s), client interactions and other areas as needed.
- Provides update / progress reports to Associate Director, Global Case Processing.
- 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 and Investigator meetings as needed.
- Supports and participates in response to client requests for proposals, as needed, in collaboration with Associate Directors and/or Directors.
Participates in bid-defense preparation and attends bid defense meeting, as needed.
- Attends and supports client audits and regulatory inspections from a pharmacovigilance operations standpoint.
- Ensures completion of employee performance objectives and development plans. Conducts annual employee performance evaluations.
- Performs additional duties as assigned by UBC Management.