Pharmacovigilance Leadership Manager

hace 1 semana

Ciudad de México, Ciudad de México ICON Plc A tiempo completo

Senior Pharmacovigilance Leadership Position

Company Overview

ICON Plc is a world-leading healthcare intelligence and clinical research organization dedicated to fostering an inclusive environment driving innovation and excellence.

Job Summary

We have an incredible opportunity for a highly experienced Senior Manager, Pharmacovigilance (Reporting Group) to join our team. The successful candidate will be responsible for managing personnel within Pharmacovigilance, providing expertise in various tasks such as Serious Adverse Events (SAE)/Adverse Reactions/Medical Device Report management, periodic safety reports, adjudication, coding, product complaints, and more.

About the Role

This role offers a unique blend of leadership, project management, and technical skills. As a Senior Manager, you will oversee the development, implementation, and monitoring of profitability, objectives, metrics of assigned group of direct reports. You will also identify and implement process improvements through review of SOPs, processes, and recommend improvement plans to senior management.

Key Responsibilities
  • Manage resources and resource projections to ensure project teams are consistent with client needs, expectations, and contractual obligations.
  • Analyze current and future project backlog in order to provide adequate resources to meet business objectives.
  • Build and align a technical team to perform critical operating tasks to achieve results.
  • Identify and implement process improvements and other ways to improve efficiencies.
  • Deliver training on department-related topics as well as general company processes and systems to Pharmacovigilance staff.
  • Liaise with other functional managers to ensure consistency of pharmacovigilance approaches within the company.
  • Maintain 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 implements contract amendments/change orders as required.
  • Ensures that staff fulfill their responsibilities in accordance with company policies, procedures, and SOPs.
Requirements and Qualifications
  • Bachelor's degree (or higher) in a healthcare-related or life science field.
  • A minimum of 8 years' experience at a senior level within Pharmacovigilance within a CRO or BPO.
  • Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.
  • Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.
  • Excellent Project Management skills.
  • Analytical mindset.
  • Fluency in Japanese would be an advantage.
Salary and Benefits

The estimated annual salary for this position is approximately $120,000-$180,000 USD, depending on location and experience. ICON offers a range of benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning, and more.

About Us

At ICON Plc, we value diversity, equality, and inclusion. We are committed to creating a workplace free of discrimination and harassment, where all qualified applicants receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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