I am Zach from Pioneer Data System, Inc. We have an immediate requirement for a Compliance Analyst / Drug Safety Case Processing in Horsham, PA. 19044
If you are interested please call me at (732) 947-(3455) or respond to this email.
Position Details:
Job Title: Compliance Analyst / Drug Safety Case Processing
Duration: 5+ months
Location: Horsham, PA. 19044
Description:
Responsible for generating quality, compliance, case receipt and pharmacovigilance agreement metrics in support of GMO/Client 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. (TYPE BELOW THIS LINE)
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.
Accountable for prioritizing and ensuring deliverables are completed on time and are accurate and consistent. Follows documented procedures for metrics generation. Consults with Manager, GMO & Vendor Compliance Oversight for complex issues and changes to processes and procedures.
Works independently to resolve routine issues and questions. Raises issues to Lead Compliance Analyst when they cannot be resolved to stakeholder / customer satisfaction or when timelines are in jeopardy.
The Senior Metrics Analyst works within a matrix environment:
Works closely with Lead Compliance Analyst to develop reports and dashboards to measure quality and compliance.
Interfaces directly with all functions impacting GMO / Client monitored quality and compliance metrics (including, but not limited to):
• Case Management
• Case Reporting
• Vendor Compliance Points of Contact
• Client
• IPV / LSO
• LOC
• QPPV
• 3rd Party Compliance Contacts
• GRA
• GCO
EDUCATION & EXPERIENCE REQUIREMENTS:
Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.
• 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.
