Senior Manager, Pharmacovigilance Lead

hace 3 semanas

Xico, México Engineeringuk A tiempo completo
Job Title: Senior Manager, Pharmacovigilance

At ICON, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a highly skilled Senior Manager, Pharmacovigilance to join our team in Mexico City.

Job Summary:

The Senior Manager, Pharmacovigilance will be responsible for managing personnel within Pharmacovigilance and providing expertise on tasks such as Serious Adverse Events (SAE) management, periodic safety reports, and adjudication. This role will also support departmental initiatives, develop SOPs, and maintain familiarity with current industry practices and regulatory requirements.

Key Responsibilities:
  • Manage personnel within Pharmacovigilance and provide expertise on tasks such as SAE management, periodic safety reports, and adjudication.
  • Support departmental initiatives, develop SOPs, and maintain familiarity with current industry practices and regulatory requirements.
  • Monitor projects to ensure company profitability and associated project goals and objectives are being met.
  • Develop, implement, and monitor profitability, objectives, metrics of assigned group of direct reports.
  • Identify and implement improvements of processes within own service area through review of project specific plans and their implementation.
  • 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.
  • Provide 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.
  • 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.
  • Support direct reports in identification of out-of-scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required.
  • Ensure that staff fulfill their responsibilities in accordance with company and/or client QMS, policies, procedures, and SOPs, as applicable.
  • Create an environment that encourages learning, self-improvement, and career development for staff.
  • Support 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).
Requirements:
  • 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.
What ICON Can Offer:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a Global Employee Assistance Programme, LifeWorks.

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