Senior Quality Assurance Specialist

2 weeks ago

Hyderabad Secunderabad Telangana, India beBeePharmacovigilance Full time ₹ 5,00,000 - ₹ 8,00,000
Job Description

The primary function of this role is to perform thorough quality assurance reviews of periodic aggregate safety reports (PASRs) submitted by Amgen, including development safety update reports (DSURs), periodic benefit-risk evaluation reports/periodic safety update reports (PBRER/PSURs), semi-annual safety update reports (SSURs), periodic adverse drug experience reports (PADER/PAERs), device PSURs, and country-specific reports such as Korea PSUR, Brazil PSUR, and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The quality assurance reviewer will ensure the accuracy, consistency, and compliance with regulatory and company standards, supporting the end-to-end writing and documentation process while ensuring timelines are met.

Key Responsibilities:
  • Conduct comprehensive quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure accuracy of content, data integrity, formatting consistency, and adherence to regulatory and internal standards.
  • Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases.
  • Collaborate closely with periodic report specialists to address discrepancies and ensure timely resolution of quality issues.
  • Maintain up-to-date knowledge of global regulatory requirements and industry best practices for periodic safety reporting.
  • Contribute to the development and refinement of QC checklists, templates, and standard operating procedures (SOPs) to standardize and improve review practices.
  • Track QC metrics and support continuous improvement initiatives related to the quality and timely delivery of safety reports.
Required Skills and Qualifications:
  • Total experience: 5-9 years in relevant roles
  • At least 2-3 years of experience specifically in quality control (QC)
  • Bachelor's or Master's degree in life sciences, pharmacy, or a related field

This role requires strong analytical and problem-solving skills, with the ability to work independently and collaboratively as part of a team. The ideal candidate will have excellent communication and interpersonal skills, with the ability to maintain confidentiality and handle sensitive information effectively.

  • Senior Quality Assurance Specialist

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878

    Our team is seeking a seasoned Senior Quality Assurance Specialist to join our ranks.Job Description:In this pivotal role, you will:Support the performance and overall effectiveness of the team, as well as cross-group complex quality assurance and assess problems and issues to ensure activities follow necessary internal and external regulatory and risk...

  • Senior Software Quality Assurance Specialist

    1 week ago

    Hyderabad / Secunderabad, Telangana, Pune, Bengaluru / Bangalore, India beBeeSoftwareQuality Full time ₹ 9,00,000 - ₹ 12,00,000

    Senior Software Quality Assurance SpecialistWe are seeking a seasoned Senior Software Quality Assurance Specialist to join our team.

  • Senior Quality Assurance Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeQuality Full time ₹ 2,40,000 - ₹ 3,60,000

    Senior Quality Assurance SpecialistAre you an experienced professional seeking a challenging role in quality assurance? We are looking for a Senior Quality Assurance Specialist to join our team.

  • Software Quality Assurance Specialist

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878

    Software Quality Assurance SpecialistAs a Software Quality Assurance Specialist, you will be responsible for ensuring the quality of our software products.

  • Senior Quality Assurance Specialist

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeQuality Full time

    Job OverviewWe are seeking a highly skilled Senior Quality Assurance Specialist to join our technology team.The ideal candidate will analyze functional requirements to gauge their impact on software applications and derive comprehensive test cases from them.They will write concise, complete, well-organized bug reports, test cases, and status reports.Actively...

  • Senior Quality Assurance Specialist

    1 week ago

    Hyderabad / Secunderabad, Telangana, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000

    Senior Quality Assurance AnalystOur team is looking for a seasoned Senior Quality Assurance Analyst to join our ranks. This is an exciting opportunity for an individual with extensive experience in software testing, quality assurance, and process improvement.Key Responsibilities:Collaborate with cross-functional teams to ensure products meet the highest...

  • Payment Quality Assurance Specialist

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeQuality Full time

    Job Title: Payment Quality Assurance SpecialistWe are seeking a highly skilled and experienced Payment Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in payment operations, testing, and quality assurance.The primary responsibility of this role is to develop and execute comprehensive testing strategies for...

  • Quality Assurance Specialist

    1 week ago

    Hyderabad / Secunderabad, Telangana, India beBeeSoftware Full time ₹ 8,00,000 - ₹ 12,00,000

    Job Title: Quality Assurance SpecialistAre you a detail-oriented professional with a passion for ensuring software quality? Do you have experience in manual and automated testing, as well as a strong understanding of software development methodologies?Our company is seeking a skilled Quality Assurance Specialist to join our team. As a key member of our QA...

  • Principal Quality Assurance Strategist

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeQuality Full time ₹ 5,00,000 - ₹ 8,00,000

    Senior Specialist, Quality Assurance Job DescriptionAs a senior specialist in quality assurance, you will play a pivotal role in enhancing the overall quality of our products. Your primary responsibility will be to develop and implement an improved QA strategy that aligns with organizational goals and boosts testing efficiency.Develop and Implement QA...

  • Quality Assurance Specialist

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeQuality Full time ₹ 15,00,000 - ₹ 28,00,000

    Quality Assurance and Control Specialist">Job Description:The role of Quality Assurance and Control Specialist involves ensuring that products meet the required standards of quality. This includes implementing and maintaining quality management systems, conducting internal audits, and reviewing and approving quality documents.Key Responsibilities:Implement...