Clinical Safety Data ManagerA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionThe Manager, Safety Data Collection, Clinical Trials is responsible for managing the Pharmacovigilance (PV) operations of Pre and Post-approval Clinical Studies globally. The employee supports the Senior Manager, Safety Data Collection, Clinical Trials and is responsible for setting the safety operations strategy, establishing the safety report collection standards and processes, and ensuring they are implemented and executed consistently throughout all Pre and Post-Marketing Clinical Studies globally. The AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives. Where relevant, when partners (e.g. Quintiles Strategic Partnership) have additional safety related responsibilities, the manager ensures proper coordination between the partner and the SABR Subject Matter Expert/function lead.Support Senior Manager, Safety Data Collection, Clinical Trials with setting the safety operation strategy and establishing the safety report collection standards and processes for Pre and Post-approval Clinical Studies globally Senior Manager, Safety Data Collection, Clinical Trials 20%Execute the development, maintenance and implementation of Controlled documents (SOPs), data handling conventions and other process documents for Clinical Trials and Post-Marketing Clinical StudiesSafety operational content and processes for Clinical Trial and Post-Marketing Clinical Study tools for report collection such as protocols, CRFs, SAE forms, Pregnancy formsTools and processes for database requirements and configurations to enable safety-related activities during studiesTraining requirements and materials for Clinical Trial safety report collectionReport metrics and KPIs for Clinical Trial safety report collection Senior Manager, Safety Data Collection, Clinical Trials 20%Oversee and ensure study safety operational requirements are operationalized Senior Manager, Safety Data Collection, Clinical Trials 15%Support the following Strategic Partner / vendor oversight activities, in conjunction with relevant functions (such as Global Clinical Operations) in relation to Clinical Trial safety report collection:Provide functional support / input to set up partner and vendor relationship (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans)Support onboarding and ongoing maintenance of partner and vendor status to perform work (e.g., access, training, technology set-up)Provide ongoing support of partners and vendors (e.g., questions, issues, meetings)Conduct partner oversight and performance management on contracted work (e.g., monitoring reports, quality evaluations, annual meetings) Senior Manager, Safety Data Collection, Clinical Trials 20%Communicates on PV legislation and regulatory commitments across the organization and externally Senior Manager, Safety Data Collection, Clinical Trials 5%Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials 10%QualificationsEducation & Experience Required:Bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences requiredMaster's or Doctorate level degree in health care related profession preferred4+ years in drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalentExperience interacting with clinical third parties (e.g., contract research organizations) preferredKnowledgeable in Pharmacovigilance and GCP legislation requiredDirect experience in GXP compliant quality systems preferredExcellent written and verbal communication skills including: technical writing skills, PC skills, ability to produce clear, concise documentation and good analytical skillsMust work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organizationEffective managerial skills, being a self-starter, ability to work independently, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritizeAbility for individual decision-making requiredMust demonstrate initiative to identify and communicate issues within department and across departmentsCommunicates study-specific requirements for AE intakeIdentifies and implements corrective and preventative actions (CAPAs) resulting from non-compliancesIdentifies and escalates compliance trends and risks in the AE intake space