This position is a member of Global Patient Safety – Global Pharmacovigilance Compliance and Safety Operations. This role encompasses support and oversight of the compliance of the GPS PV System including the responsibilities of individual case safety reporting. The Senior PV Specialist will perform quality review of work performed by the PV outsource vendor providing instruction and training as needed. This position collaborates with others outside of Safety Operations to review, correct and reconcile data.
The Senior PV Specialist ensures that all pharmacovigilance operations are appropriate in terms of structure and performance, to comply with global standards, policies and procedures related to pharmacovigilance
Essential Duties and Responsibilities
? Monitor quality of cases processed by PV outsource vendor through random QC of cases or through review of Quality Metrics
? Managing Literature searches, search-string review and other Literature related activities including article ordering, translation request, copyright order
? Managing (Literature, Clinical, Reconciliation) mailbox and Workflow manager requests
? Approval for Data-correction and nullification of cases
? Leading Safety SME meetings
? To coordinate and support testing in ARGUS related projects when required
? Providing Trainings and Certifying Vendor for Case Processing
? Managing spontaneous, solicited, clinical and literature adverse event reports as a part of a cross- functional team
? Perform reconciliation
? Participate in Safety Evaluation and Risk Assessment meetings, Data Management Plan and Safety Management Plan, perform data monitoring, AE/SAE reconciliation, and other Clinical Trails related activities.
? Interface with the safety writing and data management groups in preparation for generation of aggregate safety reports (e.g. PADER, PSUR, PBRER)
? Interface and collaborate with other organizations within client (e.g. Regulatory Affairs, IT, Legal, Customer Service, etc.)
? Collaborate with local and regional Patient Safety team members to facilitate the global exchange of safety information.
? Participate in compliance monitoring related activities including CAPA and Quality Control Metrics
? Represent GPS in broad, cross-functional or multi-divisional initiatives, and/or serve as project lead for departmental projects
? Serve as therapeutic area escalation contact for questions within GPS as well as those coming from outside GPS
? Assist with local and global PV associated projects/work streams and task forces
? Support with PV SOPs or any PV related quality documents: Creation, review, maintenance
