Compliance Analyst

Pioneer Data Systems, Inc; Horsham (PA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading compliance and pharmacovigilance firm is seeking a Compliance Analyst / Drug Safety Case Processing in Horsham, PA. The successful candidate will be responsible for developing compliance metrics, ensuring quality control, conducting User Acceptance Testing, and collaborating with internal partners. Candidates should have a Bachelor's degree and significant experience in the pharmaceutical industry, particularly in pharmacovigilance. Strong skills in Excel and PowerPoint are required. This is a 5+ month engagement.

Qualifications

• 4 years of pharmaceutical industry experience, or advanced academic degree with 2 years.
• 2 years of experience in pharmacovigilance case processing and/or PV compliance monitoring.
• Understanding of GxP requirements.

Responsibilities

• Generate and control quality and compliance metrics and presentations.
• Collaborate to ensure metrics reporting.
• Develop controlled documents and reports for quality.
• Perform User Acceptance Testing for reports.
• Prioritize and ensure deliverables are completed on time.

Skills

Intermediate Microsoft Excel

Intermediate Microsoft PowerPoint

Excellent communication and writing skills

Ability to influence without authority

Ability to function in a global matrix environment

Education

Bachelor's Degree in relevant discipline

Job description

Overview

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.

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

• 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

• Case Management
• Case Reporting
• Vendor Compliance Points of Contact
• Client
• IPV / LSO
• LOC
• QPPV
• 3rd Party Compliance Contacts
• GRA
• GCO

Education & Experience Requirements

• 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.