Leading the execution of our strategy to bring end-to-end tailored pharmacovigilance services to biotech, pharma and medical device companies.Qinecsa provides digitally enabled intake in support of ICSR processing, reducing errors and streamlining the workflow, as well as safety writing and literature management. Qinecsa also offers adaptable models to support safety data analysis, utilizing both experienced professionals and an end-to-end signal detection platform.

•Provide strategic oversight for Pharmacovigilance business unit •Contribute at a senior level to the development of internal processes, SOPs, and Work Instruction Documents related to adverse event management and reporting; identifies, leads, and implements process improvements •Significant contributions and support for internal and external audits, including FDA and other global regulatory inspections •Senior level contributor for Pharmacovigilance Group Business Development opportunities through creation of/participation in client-facing presentations (bid defense, RFI, and capabilities presentations) •Evaluate and determine appropriate resources to assign to project teams as requested for proposals and project execution •Monitor department metrics/deliverables to ensure Management team has appropriate staffing for project support •Cross-functional responsibilities in support of project management, data management, and clinical operations •Oversee and mentor pharmacovigilance Management staff, ensure training of lower level personnel and continued advancement of staff; provides to development of training curriculum •Participate in regulatory intelligence meetings to evaluate proposed, new, emerging regulation/requirements/policy changes

• Experience managing multiple high touch client relationships• Escalation point of contact ensuring client satisfaction for contracted services• Strategic business planning and initiative development; review of budgets, contracts, and service agreements• Serves as part of the Leadership Team for Pharmacovigilance services contracted with small to mid-size pharmaceutical companies• Responsible for direct reports including RNs and MDs; staff development and compliance with policies and procedures• Provides leadership and support to Managers in communicating Key Performance Indicators to the client and delivering performance improvement plans as necessary• Ensure timely communication of customer comments/complaints/needs to applicable parties and follow up to ensure prompt and appropriate response• Participate in quality assessment reviews and audits and prepare appropriate responses to findings identified• Plays key role in prospective client demonstrations • Analysis of resource requirements to support business initiatives across multiple departments and clients• Responsible for specific project milestones and standards, and ensure appropriate follow-through

•Leads a client focused unit of Adverse Event Management personnel consisting of MDs and RNs; single point of accountability for the client for contracted Pharmacovigilance and Technology services •Responsible for client engagement to assure that needs are met including review of weekly/monthly/quarterly case flow, including projections of case volume and metrics•Participates in prospective client demonstrations, including preparation of presentation and customization of materials and handouts•Assessment and clinical evaluation of medical information received used to determine need for expedited reporting of events to global regulatory authorities as required•Responsible for setting direction and goals for the team by providing guidance and expertise in the collection of a clinically relevant data, including the clinical management of cases and proper prioritization•Dedicated to meeting the expectations and requirements of internal and external customers by maintaining effective relationships; responsible for hiring and training new team members to ensure continuity and continued quality of the work provided to the client•Interfaces with global safety teams formed to assess the continuing safety profile for multiple marketed and pipeline oncology products in hematologic malignancies; provides support for development of aggregate reports and medical writing

•Collaboration with lead safety MDs in evaluation of products’ safety profiles using multiple database review to address safety concerns within Celgene clinical trials and approved products (early phase through post-approval studies)•Writing responsibilities included drafting safety sections of key trial & regulatory documents including IND Annual Reports, Clinical Study Reports, Investigator Brochure updates, Annual Study Reports, and Development/Periodic Safety Update Reports •Extensive small and large group presentation experience in educating Investigators and other study staff in Safety reporting and study conduct •Experience with protocol and case report design and review (Phase 1-3) and collaboration with Data Management; able to plan efficiently and ensure follow-through•Creation of safety reporting training for Investigator Meetings, new protocol implementations, and interdepartmental and vendor training•Assists Medical Affairs trials teams in implementing, executing and concluding trials while managing logistics of all safety aspects •Maintain knowledge of safety profiles for treatments in multiple hematologic malignancies for Celgene investigational products•Interdepartmental liaison for communications both internally across functions and externally with vendors and site personnel

•Assessment and clinical evaluation of medical information received used to determine need for expedited reporting of events to regulatory authorities as required by the FDA and EU Clinical Trial Directive•Manage serious adverse events from 9 Phase I/II/III trials across multiple approved products and for those in early pipeline development•Progressive responsibilities and autonomy within the Drug Safety team including collaboration within the Medical Affairs and with Clinical Operations•Developed and maintained relationships within the company and with company partners