Quality Assurance & Vendor Oversight Lead

Quality Assurance & Vendor Oversight Lead

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for oversight of all case intake and processing of safety information. Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Oversight of submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Provide audit & external inspection support.

• Supervision of 1-15 staff in Amgen India with responsibilities supporting case management and Pharmacovigilance Operation activities as required.
• Accountability for quality oversight of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases by all vendor case processing teams
• Supervise vendors quality ISCR metrics management to ensure all worldwide regulatory authority requirements are met
• Provide vendors with resources and training to perform their role
• Analysis and communication of case Quality Control results
• Responsible for implementation of measures for case related quality issues from vendor(s)
• Customer concern of issues around quality and key performance indicators to PV Operations leadership as applicable
• Lead vendor governance including annual updates to the applicable relationship/business plans
• Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable
• Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
• May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable
• Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor

Key Activities:

• Handling direct reports on a day-to-day basis and raising topics as needed to GPS senior leadership.
• Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes
• Oversee day-to-day local and vendor operations as outlined in the standard operating procedures and contractual agreements
• Independently handle vendor relationship
• Responsible for the growth and development of direct reports.
• Liaison with affiliates as needed regarding case management issues regarding product safety issues
• Oversee/handle correspondence associated with AE reports involving possible litigation
• Ensure monthly review of performance metrics (e.g. quality, volumes, turnaround times) as outlined in contractual agreements
• Provide subject matter expertise in the interpretation of regulations as it relates to case processing
• Participate/support in audits/inspections and responses for case related findings
• Build and maintain good functional and cross functional relationships globally

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek should possess these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of directly related experience OR
• Masters degree and 8 to 10 years of directly related experience OR
• Bachelors degree and 10 to 14 years of directly related experience OR
• Diploma and 14 to 18 years of directly related experience
• 4 years of managerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Knowledge of global regulatory requirements for Pharmacovigilance
• Extensive people management experience
• Expertise in all aspects of case management
• Experience in handling vendor relationships
• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook