Director, Global Pharmacovigilance Operations

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POST DATE 8/11/2016
END DATE 11/2/2016

Raptor Pharmaceuticals Novato, CA

Company
Raptor Pharmaceuticals
Job Classification
Full Time
Company Ref #
359989
AJE Ref #
575849265
Location
Novato, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
div class="col-sm-12 col-md-8 col-md-offset-1 col-md-push-3" strong Director, Global Pharmacovigilance Operations /strong p span span span strong Location: Novato, CA /strong /span /span /span /p p span span span strong Requisition #:  65-3500-2016N /strong /span /span /span /p p span span span strong Summary Description /strong /span /span /span /p p The Director, Global Pharmacovigilance (PV) Operations will be responsible for the oversight and management of vendor and case processing management for all clinical stage and commercial Raptor products on a world-wide basis.  The position requires an experienced leader who can be hands-on and execute the tactics as well as provide direction and strategy on process improvements and overall team effectiveness. The individual is required to effectively prepare groups for anticipated product approvals and manage increasing volume of clinical trial and post-marketing reports. The individual is responsible for ensuring key performance indicators are met/ exceeded for compliance and quality of all deliverables. The individual must maintain excellent relationships with all relevant vendors, licensed partners and other third parties internal and external to Raptor. /p p span span span strong Responsibilities /strong /span /span /span /p ul style="list-style-type:disc" li Lead the establishment and oversee the PV operational and case management activities for PV Operations including the collection, processing, and reporting/submission of safety information for all Raptor products (investigational and commercial) in accordance with all applicable regulatory requirements, Good Pharmacovigilance practices (GVP) or guidelines and Raptor’s internal operating procedures (e.g., SOPs) /li li Participate in the development, implementation and maintenance of Raptor (including vendor) PV system including policies, SOPs, and forms to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices /li li Establish, implement, and maintain Global AE training policy for Raptor and ensure Raptor’s compliance with policy internally/externally /li li Ensure compliance with all regulatory reporting requirements and timelines for reporting safety data from clinical studies and post-marketed use /li li Participate in the PV vendor evaluation and selection process as well as vendor set-up and execution of PV vendor agreements (e.g., MSA/SOW) /li li Supervise the day-today activities of, monitor and evaluate the performance and quality of PV vendor responsible for case management and other PV activities /li li Participate in the selection, implementation and maintenance of the global safety database to ensure compliance with global AE reporting requirements /li li Ensure implementation of processes and systems internally (where necessary) and externally (PV vendor) to ensure AE information is received timely, reviewed for completeness and consistency, and case follow-up activities are completed to facilitate signal detection and aggregate safety reporting activities /li li Ensure literature search strategies are performed on weekly basis and all relevant articles are assessed for adverse reactions and benefit-risk information. /li li Assume active role in development and subsequent maintenance of Raptor’s Pharmacovigilance System Master File (PSMF). /li li Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs), PV agreements, Statements of Work, manage partner relationships, and ensure compliance with PV agreements /li li Ensure reconciliation of AE reports received from other company operating units, affiliates, contractual vendors, partners, CROs, as applicable /li li Ensure SAE reconciliation of clinical and safety databases for ongoing clinical studies /li li Liaise with the EU Qualified Person for Pharmacovigilance (EU-QPPV) and Deputy-QPPV on regular basis and ensure they are kept well informed of any activities relating to PV, appropriately consulted and recommendations are acted upon /li li Serve as the PV Operations Lead for Raptor development programs; work with internal/external partners to develop procedures for AE handling and training (e.g., Investigator Meeting or Site Initiation Visit trainings) /li li Contribute to the development and maintenance of safety sections for clinical and regulatory documents (e.g. Protocols, Informed Consent, and other reports as necessary) /li li As PV Operations Lead, liaise with colleagues in but not limited to BioStatistics/Data Management, Clinical Development, Clinical Operations, Clinical Sciences, Commercial, Legal, Medical Affairs, Product Quality, Regulatory Affairs to ensure processes are in place for activities performed by those functions that impact PV including a full range of PV and cross-functional activities /li li Implement & document Corrective Action and Preventative Actions (CAPAs) as needed to ensure compliance with Raptor policies/procedures and regulations /li li Ensure PV inspection readiness internally and externally, prepare for and have a central role in PV Regulatory Authority inspections and in relevant internal/external audits; ensure subsequent Corrective Action and Preventative Actions (CAPAs) are documented and implemented as planned /li li Provide support to other Regulatory or business partner inspections as needed. /li li Contribute to safety requests from Regulatory Authorities /li li Serve as PV Operations Lead for organized data collection activities such as Patient Support Programs and Investigator Initiated Trials/Studies /li li Ensure global PV regulations are monitored for updates and that changes are implemented as appropriate /li li Ensure document management system for management, retrieval, and archiving /li li Provide training, coaching and mentorship to PV & other Raptor staff /li li Other duties as assigned /li /ul p span span span