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Director Phamacovigilance Operations
Durham, NC 27703 United States
Looking for a high energy pharmacovigilance professional wanting to make the next step up. This is an opportunity to join a growing, 1st in class Pharmacovigilance CRO, located in North Carolina. Our organization that has a 17 year track record of success and looking to expand its horizons. We are looking for a motivated, results oriented PV Operations Director with a strong work ethic.
Provide overall direction, guidance and management of Operations Managers and operational processes for one or more assigned client teams. Collaborate cross functionally to develop strategic plans ensuring that client and Ashfield PV needs are met. Ensure team compliance with Ashfield PV SOPs and WPs. Ensure staff development through appropriate training and regular evaluation and feedback. Identifies inefficiencies and problems. Recommends and implements solutions. Work with Operations Managers to analyze operational processes and develop tactics to maximize operational efficiency. Responsible for oversight of a range of client support activities including proposal development, communication, training and audit preparation. As both a Director and a member of Management, this position will participate in strategic planning and implementation of key business objectives and ensure implementation and management of initiatives within their business function.
Knowledge, Skills and Abilities:
Comprehensive understanding of all applicable international regulatory requirements and guidelines surrounding pre- and post-approval safety management activities with reporting of adverse event information. Working knowledge of MedDRA. Advanced skills in safety databases (i.e. Argus, PV Works). Ability to forecast case volume, personnel needs, and budget requirements and to track financial accounts status. Demonstrated leadership ability with strong team building and personnel development and management skills. Demonstrated conflict management skills. Ability to work across functions to ensure that business objectives are met. Resource utilization analysis and planning skills. Ability to work independently and problem solve with focus on Ashfield PV objectives. Ability to work in an environment of rapidly changing priorities while managing multiple activities and assignments. Able to effectively delegate to others. Communicate effectively in English, both orally and in writing. Maintain client and corporate confidentiality. Ability to develop Ashfield PV SOPs and WPs. Proficiently utilize MS Office and other required software.
Essential Duties and Responsibilities:
•Responsible for adherence to Ashfield PV’s pharmacovigilance operations policies and reports any deviations to the COO.
•As a member of the management team, participate in strategic planning, evaluation, and professional development initiatives.
•Responsible for assessing whether strategic initiatives within the pharmacovigilance operations function are in line with Ashfield PV’s standards and objectives.
•Provide vision, leadership, strategic planning and coordination of pharmacovigilance operations. • Develop standard operating procedures and best practices, including providing written protocols and guidance to pharmacovigilance operations staff.
•Manage Operations Managers to effectively evaluate, motivate, delegate and monitor their activities.
•Responsible for personnel management, including hiring, development, coaching and managing performance.
• Implement and maintain one-on-one and team meetings with Operations Managers.
•Lead and manage Operations Managers to ensure deliverables are met while maintaining high quality standards.
•Work collaboratively with Operations Managers and other functional areas to meet all company goals and objectives.
•Assist Operations Managers with oversight of Ashfield PV client projects ensuring consistency with regulations, standard form usage, SOPs, WPs, and client-specific documentation. • Manage procedure deviations and corrections from Ashfield PV SOPs and WPs using the CAPA management system.
•Efficiently utilize tools and metrics (e.g. Dashboard Reports, Quality Metric Report) to supervise staff output, timelines, and quality of work product. Advises Operations Managers on adjustments needed to staffing levels and operational processes to ensure operational effectiveness.
•Oversee team resource utilization, deliverables, productivity, work flow structure and quality standards to ensure accuracy, efficiency and on time delivery of service to clients.
•Oversee case volume forecasting and analysis and scope of work.
•Oversee the management of client accounts, including but not limited to review and negotiation of contracts, change orders and invoicing/payment.
•Ensure all applicable client specific documentation is developed, fully executed and updated in a timely manner.
•Ensure alignment of work performed is in conformance with contractual requirements.
•Review and update project status metrics in a timely manner as requested.
•Use personal judgment and initiative to develop effective and constructive solutions to challenges and obstacles.
•Complete required training and develop relevant knowledge, techniques and skills as necessary. • Participate in internal and external audits, responding to any quality issues identified.
•Communicate, liaise, and negotiate internally and externally using appropriate methods to facilitate the development of profitable business and sustainable relationships, business growth, client and staff satisfaction.
•Participate and collaborate effectively in a cross-functional/matrixed environment.
•Partner with Program Directors to ensure adherence to client onboarding and off-boarding procedures.
•Assess ongoing pharmacovigilance needs and identify potential new business opportunities among existing clients. Collaborate with Program Directors and Operations Managers on new business opportunities.
•Use solid problem solving skills and utilize confirmed data for problem solving. Evaluate all possible methods for resolving an issue and be able to present proposed solutions in a clear, concise and data driven manner to matrix teams and senior management.
•Communicate with senior management via monthly project review meetings regarding status of accounts.
•Work collaboratively with Client Services team and escalate issues with potential risks to senior management.
•This is a key position within the company and because of the nature of the role, would create substantial challenges for the company during sustained absences or failure to effectively manage all functions within role.
•Other duties as assigned.
Directly supervises Operations Managers. Carries out supervisory responsibilities in accordance with Ashfield PV’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and coaching employees; addressing complaints and resolving issues.
Bachelor’s degree in a healthcare of science related field; graduate degree in business or healthcare related field. Minimum of eight years clinical and post-marketing pharmacovigilance experience to include a minimum two years of senior pharmacovigilance management experience as an Associate Director or Director in a CRO, and a minimum of two years of mid-level pharmacovigilance workflow and personnel management.
Travel: Ability to travel in US and internationally. Estimate 30% travel.
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