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Senior Manager, Pharmacovigilance
4 months ago
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
Roles & Responsibilities:
That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
• Monitors projects to assure company profitability and associated project goals and objectives are being met.
• May serve as the main point of contact for the customer for the life-cycle of assigned stand alone projects and programs, and the main pharmacovigilance point of contact for assigned full-service projects
• Develops, implements, and monitors profitability, objectives, metrics of assigned group of direct reports.
• Identifies and implements improvements of processes within own service area through review of project specific plans and their implementation; recommends improvement plans to projects.
• Manages resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligations.
• Analyzes current and future project backlog in order to provide adequate resources to meet business objectives.
• Builds and aligns a technical team to perform critical operating tasks to achieve results.
• Identifies and implements process improvements and other ways to improve efficiencies.
• Provides technical oversight of the generation of project plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans, in close cooperation with project team during set-up phase.
• Delivers training on department related topics as well as general company processes and systems to Pharmacovigilance staff.
• Liaises with other functional managers to ensure consistency of pharmacovigilance approaches within the company.
• Maintains familiarity with current industry practices and regulatory requirements that affect services provided by the assigned service area.
• Reviews Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager group-related project tasks; provides leadership in the delivery of related services to clients.
• Supports direct reports in identification of out of scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required
• Ensures that staff fulfill their responsibilities in accordance with company and/or client QMS, policies, procedures, and SOPs, as applicable.
• Creates an environment that encourages learning, self-improvement and career development for staff.
• Supports the development and implementation of training for Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant or other personnel within Pharmacovigilance.
• Recommends and supports implementation of performance and productivity improvements within assigned service area to ensure optimal utilization of billable staff.
• Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.
• Identifies and implements process improvements through review of SOPs, processes; recommend improvement plans to senior management.
• Participates in task forces to implement process improvement initiatives.
• Builds teamwork and improves process and productivity by working within and across functional areas.
• Develops company employees to ensure high quality work performance and retention of high quality employees.
• Ensures staff development and performance feedback are provided through activities such as mentorship and career development.
• Develop staff for succession planning, i.e., develop next generation of management/leaders
• Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities.
• Involved in the recruiting processes for new employees within the assigned service area.
• Assists with bringing new business opportunities to the company and maintaining existing clients' relationships for repeat business.
• Interacts with clients and participates in client meetings as necessary to support and maintain new business.
• Participates in business development initiatives, including presentations and proposal development.
• Ensures that timely and accurate information is submitted on all proposal efforts.
• Supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed.
• Coordinate interdepartmental activities (e.g. quality control processes, quality assurance (audits), miscellaneous project activities)
• Prepares Standard Response letters, including conducting literature search, article summary etc.
• Responsible for vendor management (e.g. LPPharmacovigilance)
• Supports Qualified Person for Pharmacovigilance as required.
• Management of assigned safety and/or medical information call center handling teams to ensure project and departmental deliverables are being met.
• Develop and maintain working procedures on literature activities for PharmacovigilanceSS department. Review and approve search strategies for all literature projects. Oversee set-up of literature projects as per client/sponsor requirements, training, recruitment and development of literature team. Support management with inputs on literature team metrics and other relevant data as needed. Provide support for revenue forecasting, financial overview and business development for literature projects.
• May serve as Local/Qualified Person for Pharmacovigilance (including deputy level)
• Displays expertise in the position by:
o Leading a process development / improvement task force or CAPA team
o Developing tool(s) to improve Pharmacovigilance processes
o Acting as a Subject Matter Expert (SME) for various technologies or processes
o Develops and delivers training courses on Pharmacovigilance related topics to ICON employees within and outside Pharmacovigilance, as well as to external parties (investigators, clients).
• Displays an industry presence by:
o Writing articles for industry publications
o Giving presentations at industry conferences
o Obtaining industry certifications
• Represents the assigned Pharmacovigilance service area as part of global initiatives impacting Pharmacovigilance, and makes decisions autonomously, with little direct supervision required.
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
