Job title: Quality Specialist

Company: Varite

Job description: POSITION SUMMARY: Briefly state the objective of this position. (TYPE BELOW THIS LINE) The Senior Aggregate Report Quality Specialist is primarily responsible for the quality review of Pharmacovigilance Aggregate Reports and other key work products (

POSITION SUMMARY: Briefly state the objective of this position. (TYPE BELOW THIS LINE) The Senior Aggregate Report Quality Specialist is primarily responsible for the quality review of Pharmacovigilance Aggregate Reports and other key work products (as defined by Senior Leadership) produced within the Global Medical Organization (GMO) and the Office of Consumer Medical Safety (OCMS) or produced by a vendor on behalf of these organizations. Also responsible for oversight checks of quality review work performed by vendors for both GMO and OCMS product portfolios. Maintains the Compliance Strategy and Analytics (CSA) Aggregate Report Quality incoming requests and daily mailbox activities. Acts as a quality liaison to other functional areas. Leads quality improvement initiatives and department training as needed. Participates in audits and inspections as Subject Matter Expert of the quality review processes for aggregate reports and/or provides CSA support. PRINCIPAL RESPONSIBILITIES: List major responsibilities and duties of the position, including delegated duties. 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) % OF TIME Perform a comprehensive Quality Control Review for report accuracy (data review) and uniformity on assigned aggregate reports within designated timelines. Document quality review findings 40% Perform quality oversight check of pharma and consumer quality review work performed by vendor team. Perform a monthly vendor quality review assessment and checklist oversight. 20% Liase with stakeholders and/or lead workstreams and trainings to improve aggregate report quality (as required) 10% Complete monthly aggregate report quality metrics 10% Maintain CSA Aggregate Report Quality mailbox for incoming requests and communications between report owners/vendor. 5% Participate in audits and inspections as Subject Matter Expert of Aggregate report quality review processes as required. Provide other CSA audit support as needed. 5% Create and/or update controlled documents as required. 5% Other duties as assigned (e.g. training participation, presentations, etc.). 5% DECISION-MAKING AND PROBLEM-SOLVING: Describe the types of decisions which are made, reviewed or referred. Describe the types of problems solved or referred. Indicate the degree to which decisions made and problems solved are circumscribed by procedure, policies, standards, or regulations. (TYPE BELOW THIS LINE) Accountable for prioritizing and ensuring deliverables are completed on time and are accurate and consistent. REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides. Reports to Associate Director, Individual and Aggregate Report Quality. DELEGATION/BACKUP INFORMATION: List duties of this position that are delegated to another party with indication of responsible job title. Also describe, as appropriate, nominated person contact details, 24-hour availability & backup information. Duties delegated as needed: Quality review of applicable documents, monitoring of CSA Aggregate Report Quality mailbox, workload triage to vendor and vendor performance oversight, metrics. WORKING RELATIONSHIPS/INTERFACES: Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature. The Senior Aggregate Report Quality Specialist works within a matrix environment: Works closely with GMSO staff, particularly Physician/Scientist, specifically Product Safety Evaluation and Reporting, GMS Risk Management Scientist, Bioresearch Quality and Compliance, Vendor Capacity Management Team and other Compliance Strategy and CSA Metrics and CSA Vendor teams. May interact with Document Specialists with the Information Technology Center of Excellence, Medical Affairs and Regulatory Affairs. 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 (Science, Medical, etc.) with 3 years of pharmaceutical industry experience, or 5 years of pharmaceutical experience within pharmacovigilance. Experience in a quality, compliance or case processing role highly desirable . Understanding of GxP requirements. . Global pharmacovigilance experience preferred. .Ability to function in a global matrix environment. . Excellent communication and writing skills. .Ability to achieve deliverables and manage and resolve issues independently. . Proven experience developing presentations for different levels of management. .Experience with Microsoft Excel and Microsoft PowerPoint required.

Expected salary:

Location: India

Job date: Wed, 20 Jul 2022 22:20:47 GMT

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