Senior Manager, Pharmacovigilance

Senior Manager, Pharmacovigilance - Mexico, Mexico City

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We have an incredible opportunity for a Senior Manager, Pharmacovigilance (Reporting Group) to join the team.

Location:

• Mexico City (office-based with remote flexibility)

Overview of the Role:

Manages personnel within Pharmacovigilance and has expertise with regards to the tasks of the subordinated group (E.g. may provide services for Serious Adverse Events (SAE)/Adverse Reactions /Medical Device Report management in writing or by phone, periodic safety reports, adjudication, coding, product complaints). Supports departmental initiatives and development of SOPs, investigation of process-related issues, consulting on safety processes, tools, and regulatory compliance. Maintains familiarity with current industry practices and regulatory requirements that affect services provided by the assigned Pharmacovigilance service area. Ensures that staff fulfill their responsibilities in accordance with company policies, procedures, and SOPs.

Supports successful completion of projects on-time, within budget limits and with approved quality levels to support achievement of the department's overall financial and quality goals and objectives. May serve as the main point of contact for the customer for the life-cycle of assigned stand-alone safety and medical information projects, and the main pharmacovigilance point of contact for assigned full-service projects.

The role:

• 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.
• Coordinates 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).

To be successful you will need:

• 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.

What ICON can offer you:

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. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

ICON, including subsidiaries, 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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.