Marketed Product Safety Associate Director

hace 3 semanas

Ciudad de México IQVIA A tiempo completo

Support the development of project objectives, budget, and scope
- Develop and maintain project documentation associated with delivery and coordination of local QPPV/national contact for pharmacovigilance activities.
- General project management administration activities
- Manage notifications to support updates to Regulatory Intelligence Database (RID) (i.e. updates to Health Authority requirements as provided by Local QPs)
- Contribute to PSMF (new /updates) for Local QPPV sections
- Act as National PSSF Coordinator, if required
- Performance monitoring, including oversight of performance of local QPPVs/national contacts against standard work instructions and procedures
- Routine status reporting on overall progress, including coordination and management of monthly QPPV/national contact activity reports
- Hosting client/local QPPV stakeholder meetings as required by Project
- Ongoing assessment of project risk and issue mitigation
- Provision of support with routine audits and inspections
- KPI monitoring
- Escalation point for issues associated with Local QPPV network
- Assist in the coordination of projects and resources, ensuring quality deliverables to customers.
- May contribute to discussions with clients on project deliverables as appropriate. Ensure staff have a consistent understanding and positive impression of business strategy for regional and global objectives.
- May have financial responsibility and accountability for team
- Responsible for monitoring growth and performance.
- May take a proactive role in developing long standing relationships with IQVIA customers, and may take a leadership role in bid defense strategy and planning, as appropriate.
- Improve Local QPPV, and pharmacovigilance agreement procedures and standards. May participate in quality or process improvement initiatives.
- Act as primary interface for customers and provide expert input on delivery of Local QPPV services required by assigned customers.
- Represent QPPVs and PVA staff on task forces as needed.
- Provide advice, support, guidance and training as needed and serve as a mentor to colleagues.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
- Performs other duties as required.

**Requirements**:

- Bachelor's Degree in health science or related area
- 2 years' clinical research experience in a Contract Research Organization or Pharmaceutical company, including at least 8 years pharmacovigilance experience. Equivalent combination of education, training or experience.
- English advanced.
- Excellent knowledge of Lifecycle Safety processes.
- Excellent attention to detail and accuracy and maintain consistently high quality standards.
- Excellent written and verbal communication skills.
- Effective mentoring skills.
- Ability to work effectively on multiple projects simultaneously.
- Organize own workload and effectively time manage competing priorities.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.

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