Case Management QA Vendor Associate

1 day ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 5,00,000 - ₹ 12,00,000 per year

*What you will do*

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. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support.

  • Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors
  • Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements
  • Provide vendors with resources and training to perform their role
  • Analysis and communication of case Quality Control results
  • Responsible for escalation of case related issues from vendor(s)
  • 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 Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes
  • Ensure vendor case processing timelines for AE intake, triage and submission are met
  • Perform retrospective quality assurance of vendor processed cases
  • Day-to-day vendor management issues
  • Interact with other local safety offices as applicable
  • Support on-boarding and off-boarding of vendor staff
  • Attend management meetings with vendors
  • Support analysis of QC trends
  • Support generating, communicating, and archiving of reports of QC findings
  • Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
  • Perform case review as required
  • Generate and distribute performance metrics (retro QA / Case correction)
  • Support analysis of QC trends including actions/recommendations

Basic Qualifications:

  • Bachelors degree and 3 years of directly related experience (OR)
  • Associates degree and 5 years of directly related experience (OR)
  • High school diploma / GED and 7 years of directly related experience (AND)
  • Previous experience directly managing teams, projects, programs or directing the allocation of resources

Preferred Skills:

  • Understanding of global regulatory requirements for pharmacovigilance
  • Proficiency in safety case processing
  • Expertise in all aspects of case intake and processing in multiple global safety databases
  • Experience in supporting inspections or internal audits
  • Communication skills and attention to detail
  • Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

  • Case Management QA Vendor Sr Associate

    1 day ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Case Management QA Vendor Sr Associate*What you will do* 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...

  • Qa Lead

    5 days ago

    Hyderabad, Telangana, India Tekfriday Processing Solutions Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Job Title: QA LeadJob Location: Hyderabad Work Mode: 5 Days In officeJob Description - QA Lead We are looking for a highly motivated and experienced QA Lead to oversee and guide our QA team, focusing on database testing and overall product quality. The QA Lead will be responsible for managing a small team of QA associates, planning and executing test...

  • QA Manager

    2 weeks ago

    Hyderabad, Telangana, India Teradata Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Our CompanyAt Teradata, we believe that people thrive when empowered with better information. That's why we built the most complete cloud analytics and data platform for AI. By delivering harmonized data, trusted AI, and faster innovation, we uplift and empower our customers—and our customers' customers—to make better, more confident decisions. The...

  • Qa Manager

    4 weeks ago

    Hyderabad, Telangana, India MTAP Technologies Full time

    Job DescriptionKey Deliverables- Lead QA strategy, planning, and execution for multiple web/mobile products- Develop and run automation test scripts aligned to agile sprints- Collaborate with developers to define acceptance criteria and improve test coverage- Support customer escalations with analysis and testing resolutionsRole Responsibilities- Own test...

  • Only 24h Left) Associate Qa Tester

    4 weeks ago

    Hyderabad, Telangana, India Electronic Arts Full time

    Associate QA TesterSummaryEA diverse portfolio features original and licenced IP titles like Covet Fashion Design Home Diner DASH Adventures Disney Sorcerer s Arena Kim Kardashian Hollywood and MLB Tap Sports Baseball Glu s culture is 10 rooted in promoting creativity to deliver world-class mobile experiences for players around the world Find roles...

  • Vendor Manager

    2 weeks ago

    Hyderabad, Telangana, India Hylenr Technologies Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Position: Vendor ManagerLocation: HyderabadExperience: 8-12 yearsEmployment Type: Full-timeAbout Hylenr:Hylenr Technologies is a groundbreaking company at the forefront of clean energy innovation. Founded by a team of visionary scientists and engineers, Hylenr is dedicated to revolutionizing power generation through its cutting-edge Low Energy Nuclear...

  • QA - Lead

    5 days ago

    Hyderabad, Telangana, India TekFriday Processing Solutions Pvt Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    We are looking for a highly motivated and experienced QA Lead to oversee and guide our QA team, focusing on database testing and overall product quality. The QA Lead will be responsible for managing a small team of QA associates, planning and executing test strategies, and ensuring seamless collaboration with development and product teams. This role requires...

  • Vendor Manager

    2 weeks ago

    Hyderabad, Telangana, India Hylenr Technologies Private Limited Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Position:Vendor ManagerLocation:HyderabadExperience:5+ YearsEmployment Type:Full-timeAbout HylenrHylenr Technologies is a groundbreaking company at the forefront of clean energy innovation. Founded by a team of visionary scientists and engineers, Hylenr is dedicated to revolutionizing power generation through its cutting-edge Low Energy Nuclear Reactor...

  • Vendor Manager

    1 day ago

    Hyderabad, Telangana, India Speriti Solutions Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Company DescriptionSperiti Solutions is an Information Technology Company headquartered in Texas with offices in Toronto (Canada), Amsterdam (Netherlands), and Hyderabad, India. We specialize in providing technology solutions to a diverse range of customers from small/mid-size businesses to Fortune 500 companies. Our goal is to let our customers focus on...

  • IT QA Analyst

    2 weeks ago

    Hyderabad, Telangana, India Assurant Full time ₹ 5,00,000 - ₹ 8,00,000 per year

    IT QA Analyst, GCC-AssurantYour role will include analyzing user stories, developing and executing test cases, and documenting defects across application systems, services, and related software components, all in support of delivering high-quality solutions that meet enterprise standards. You will impart knowledge to other team members, help them develop...