- Responsible for generating quality, compliance, case receipt and pharmacovigilance agreement metrics in support of GMO/GMS and performing quality control of standard and ad-hoc metrics and presentations. Supports audits and inspections globally, as subject matter expert for generation of compliance and quality metrics.
- Performs User Acceptance Testing for new quality and compliance reports. Participates in cross-functional projects focused on process improvement and innovation.
- Supports internal and external customers by developing custom dashboard and presentations. Analyzes data for trends and generates presentations of significant trends for various audiences
PRINCIPAL RESPONSIBILITIES: List major responsibilities and duties of the position. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. Describe those quantitative aspects of the position which reflect measures that are applicable to the position’s major responsibilities or end results.
- Generation and quality control of standard and ad-hoc quality and compliance metrics, presentations and dashboards.
- Collaborate with internal and external partners and stakeholders to ensure quality and compliance metrics are reported and/or reconciled in a timely manner. Escalate non-compliance to management.
- Manage reporting and meeting schedules.
- Develop and update controlled documents.
- Perform User Acceptance Testing for new quality and compliance reports.
- Other duties as assigned.
- Minimum of Bachelor’s Degree in relevant discipline (Business, Science, Medical, Operations, etc.) with 4 years of pharmaceutical industry experience or advanced academic degree with 2 years of pharmaceutical industry experience.
- Minimum of 2 years of experience in pharmacovigilance case processing and/or PV compliance monitoring.
- Intermediate Microsoft Excel and Microsoft PowerPoint skills required
- Understanding of GxP requirements.
- Global pharmacovigilance experience required with knowledge of global PV laws and regulations.
- Ability to function in a global matrix environment.
- Excellent communication and writing skills. Ability to influence without authority.
- Proven experience developing and conducting presentations for different levels of management; ability to tailor presentations to the appropriate level of detail.
Regards,
Nagesh
Sr.Technical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
Direct# 732-429-1641
(BOARD) # 732-549-2030 – Ext - 305
LinkedIn: https://www.linkedin.com/in/nageshghanti
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
