Senior Pharmacovigilance Manager

hace 4 semanas

Xico, México Icon A tiempo completo

At ICON plc, a world-leading healthcare intelligence and clinical research organization, we are seeking a highly skilled and experienced Senior Pharmacovigilance Manager to join our team.

The successful candidate will be responsible for managing personnel within Pharmacovigilance and providing expertise in tasks such as Serious Adverse Events (SAE) management, Adverse Reactions, Medical Device Report management, periodic safety reports, adjudication, coding, and product complaints.

The role will also involve supporting departmental initiatives, developing SOPs, investigating process-related issues, consulting on safety processes, tools, and regulatory compliance, and maintaining familiarity with current industry practices and regulatory requirements.

The ideal candidate will have a strong background in pharmacovigilance, excellent leadership and communication skills, and the ability to work effectively in a team environment.

Key responsibilities will include:

  • Supporting direct reports in monitoring of their projects to ensure company profitability and associated project goals and objectives are being met.
  • Developing, implementing, and monitoring profitability, objectives, metrics of assigned group of direct reports.
  • Identifying and implementing improvements of processes within the assigned service area through review of project specific plans and their implementation.
  • Managing resources and resource projections to ensure project teams are consistent with client needs, expectations, and contractual obligations.
  • Analyzing current and future project backlog in order to provide adequate resources to meet business objectives.
  • Building and aligning a technical team to perform critical operating tasks to achieve results.
  • Identifying and implementing process improvements and other ways to improve efficiencies.
  • Providing 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.
  • Delivering training on department-related topics as well as general company processes and systems to Pharmacovigilance staff.
  • Liaising with other functional managers to ensure consistency of safety management approaches within the company.
  • Maintaining familiarity with current industry practices and regulatory requirements that affect services provided respective service area.
  • Reviews Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager and Pharmacovigilance Project Lead, Pharmacovigilance Assistants, group-related project tasks; provides leadership in the delivery of related services to clients.
  • 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, Pharmacovigilance (Senior) Project Manager and Pharmacovigilance Project Lead, Pharmacovigilance Assistants, or other personnel within the assigned service area.
  • Recommends and supports implementation of performance and productivity improvements within the 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.
  • Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities.
  • Involved in the recruiting processes for new employees in the assigned service area.
  • Assists with bringing new business opportunities to the company and maintaining relationships with clients and partners.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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