Associate Director, Global PharmacovigilanceExpress Scripts Holding Company - Blue Bell, PA
Associate Director, Global Pharmacovigilance
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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.
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
Supervision of global pharmacovigilance staff (n= 4-6 direct reports) and 20-40 indirect reports.
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.
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 travel from time to time to UBC locations, clients, and professional/scientific meetings.
ABOUT THE DEPATMENT
United BioSource Corporation (UBC), a subsidiary of Express Scripts, 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.
UBC aligns with Accredo and CuraScript SD, also part of the Express Scripts family, to provide best-in-class, integrated services.
ABOUT EXPRESS SCRIPTS
Advance your career with the company that makes it easier for people to choose better health.
Express Scripts is a leading healthcare company serving tens of millions of consumers. We are looking for individuals who are passionate, creative and committed to creating systems and service solutions that promote better health outcomes. Join the company that Fortune magazine ranked as one of the Most Admired Companies in the pharmacy category. Then, use your intelligence, creativity, integrity and hard work to help us enhance our products and services. We offer a highly competitive base salary and a comprehensive benefits program, including medical, prescription drug, dental, vision, 401(k) with company match, life insurance, paid time off, tuition assistance and an employee stock purchase plan.
Express Scripts is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, national origin, age, veteran status, disability, or any other protected class. Applicants must be able to pass a drug test and background investigation. Express Scripts is a VEVRAA Federal Contractor.
8 days 17 hours ago
Express Scripts Holding Company
applyAssociate Director, Global Pharmacovigilance Express Scripts Holding Company - Blue Bell, PA, United States
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