C3iHC, a Telerx company, is seeking a Vice President, Pharmacovigilance - the key leader of our pharmacovigilance business. This position oversees and directs operations, processes, procedures, and leadership of the Pharmacovigilance business to drive the attainment of key performance metrics for on-time delivery, responsiveness, profitability, compliance, operational excellence and client satisfaction.
The leader in this role will:
Direct the performance on all PV business to meet/exceed all client and company expectations and contractual requirements.
Ensure Key Performance Indicators (KPI's) to drive quality, compliance, efficiency and value are achieved for all clients.
Support all new sales efforts with specific Subject Matter Expertise (SME), pricing development via Level of Efforts (LOEs) and Statement of Work (SOW) development.
Oversee the implementation of new or expanding client business. Develop and maintain consultative, appropriate senior client relationships and plan new growth opportunities.
Establish global operational capabilities via ramping the PV operational team in Sofia, Bulgaria and effectively integrating into the overall delivery model.
Responsible for the PV business P&L
Directs staff in the development, implementation, and documentation of standard operating procedures (SOPs) to ensure compliance with domestic and worldwide regulatory and relevant internal requirements.
Oversee the definition, development, and management of account maintenance and account planning processes including overall responsibility for client issue resolution and client quality
Supervise the Account Directors who serve as the primary liaison between the ongoing operation teams and client contacts. Attend all internal client reviews and external client meetings
Ensure seamless operational linkages and business process definition across all services provided to the account (s)
Direct operational planning for upcoming client business events (re-alignments, expansions, new application launches, etc.)
Direct the performance of frequent reviews of client operational metrics, translate metrics to business information, and oversee the development of action plans
Review, approve, and present to the client all proposals, statements of work, and quotes for services. Facilitate meetings with appropriate business owners and the client to finalize all pricing and contractual documents
Leverage processes to coordinate opportunity identification and business development to expand current service offerings as well as sell new service offerings to the client
Consult with client on industry trends and best practices related to services being provided by Telerx/C3i or provided by client resources
Develop and sustain a high level relationship with clients at an executive level as well as with all internal resources
Work with Operational Leaders across all locations to continuously optimize Service Delivery such that it meets clients' requirements overall while also fitting within ISO based standard processes
Liaise with internal and external customers to provide Pharmacovigilance expertise with particular emphasis on regulatory reporting. Support and interact with client and regulatory contacts concerning adverse event documentation.
Ensure standardization and optimization of case entry from both a safety system and process perspective to include compliance with SOPs, internal and external regulatory agencies and standards.
This role requires a Bachelor’s degree, preferably in a life science or health care discipline and an advanced degree is preferred. A minimum of 10 years’ experience in Pharmacovigilance,drug safety or related industry is required with progressively responsible leadership positions. 5 to 10 years’ experience and demonstrated success in leading high performing teams.
The successful leader will have:
working familiarity with the interactions between the businesses that comprise the pharmaceutical industry
broad comprehensive knowledge of pharmacovigilance and drug safety including reporting requirements and relevant legislation.
exceptional people and thought leadership skills, with the ability to think strategically and to influence others.
proven organizational leadership with a knowledge of safety systems for collection of adverse experience information
previous experience in a service provider environment along with previous experience managing a P&L.
C3i Solutions is a world-wide business process outsourcer specializing in the multi-channel engagement of consumers, patients, healthcare professionals and enterprise personnel via a network of global contact centers.
Our unique customer-centric approach has made C3i Solutions the partner of choice for some of the world’s most trusted brands for more than 30 years. C3i Solutions provides unpa...ralleled 24/7 support to customers in over 100 countries speaking 30 different languages.
With strategic focus on innovation and regulatory compliance, C3i Solutions handles more than 35 million interactions per year, helping our clients build and protect their brands while maximizing productivity and cost efficiencies. More than 90 percent of the company’s clients are FDA-regulated.