Pharmacovigilance Team Manager (London)
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.
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 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.
- 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.
- 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.
- Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations.
- Ensures completion of employee performance objectives and development plans and conducts annual employee performance evaluations.
- 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.
- Strong leadership, analytical, and organizational skills required.
- Strong written and verbal communication skills.
- 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.
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety. While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management.
Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
By combining insight from data, understanding patient behavior, and the science behind clinical specialties, we can help our clients make informed decisions and optimize the care given to patients using their therapies and products.
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