UBC - Associate Director / Director, Pharmacovigilance - Process Excellence
Company: United BioSource Corporation.
Location: Geneva, Switzerland
Closing Date: 22 Oct 16
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive Package
Responsible for establishment of standardized quality metrics for the UBC Global PV Department and for PV projects contracted by UBC clients. Responsible for the development and maintenance of the UBC PV procedural documents and for serving as the lead global PV trainer. Responsible for the prioritization and dissemination of information relating to global PV Safety Regulatory Intelligence.
Since 2003, UBC has been the home for people who are passionate about innovation, service and making a difference in peoples' lives and in the healthcare and biotech industries. As a service organization, UBC employees are our greatest resources. Their skills and expertise are what sets us apart in the industry.
Working here, you will support the development of life-changing therapies. You will work with peers who will become friends and leaders who listen to your feedback in a collaborative, innovative and fast-paced culture. You will enjoy competitive benefits, pay-for-performance compensation and rewarding recognition that promotes internal quality and critical alignment of our business objectives. And finally, you will enjoy the vast network of resources of our Fortune 20 parent organization, Express Scripts.Brief Description:
Responsible for establishment of standardized quality metrics for the UBC Global PV Department and for PV projects contracted by UBC clients. Responsible for the development and maintenance of the UBC PV procedural documents and for serving as the lead global PV trainer. Responsible for the prioritization and dissemination of information relating to global PV Safety Regulatory Intelligence. Specific Job Duties:
- Responsible for monitoring global regulatory reporting compliance by providing metrics for 7/15/90- day individual case safety reports (ICSRs) and for periodic safety reports per UBC client and product to appropriate UBC leaders.
- Ensures the timely completion of root cause analyses of any non-compliance with UBC and/or project specific processes and corresponding corrective and preventative actions (CAPAs).
- Generates productivity metrics from Argus per UBC PV user utilizing PV specific tools and processes.
- Generates quality metrics for all PV processes at UBC and project level, e.g. Ensures data entry guidelines are consistently applied across UBC PV projects via the development of a quality control sampling process.
- Ensures timely completion of audit and inspection CAPAs relating to PV processes and procedures in collaboration with PV Directors.
- Reviews root causes and CAPAs periodically with UBC PV Leadership to identify trends.
- Provides support for the generation and maintenance of standard operating procedures (SOPs), working Practices (WPs), Business Continuity Plans, for the global PV organization to ensure global regulatory reporting compliance for adverse experience reports.
- Oversees the collection, dissemination, and prioritization of global PV information identified by the Safety Regulatory Intelligence group. Ensures that global SOPs are up-to-date and that staff are appropriately trained.
- Provides notification to Project Managers of changing regulations to ensure that client plans concerning adverse experience reporting are up-to-date.
- Works with UBC Quality Trainer to ensure new employees in PV complete the PV specific training plan. Ensures that refresher training for UBC concerning the reporting of adverse experiences is completed according to schedule.
- Provides PV specific training on regulatory driven changes to UBC processes and procedures.
- Conducts regular meetings with his/her direct PV reports.
- Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations as needed.
- Attends client operational Face to Face 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 for direct reports. Conduct annual employee performance evaluations.
- Supervision of global pharmacovigilance staff (3-6 direct 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 Operations including team management responsibilities.
- Advanced knowledge of global and local PV regulations and legislation, both pre- and post-marketing 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 the development of a PV Quality Management System and in utilization of Six Sigma methodologies and tools preferred.
- Ability to travel from time to time to UBC locations, clients, and professional/scientific meetings.
*LI-AF1-UBCNO AGENCIES PLEASE