Safety Quality Specialist

3 days ago

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

We are seeking a skilled professional to conduct thorough quality control reviews of periodic safety reports, ensuring content accuracy, data integrity, and consistency.

Responsibilities include verifying correct incorporation of safety data, narratives, tables, and appendices, as well as collaborating with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues.

Additionally, the successful candidate will maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting, contribute to the development and refinement of QC checklists, templates, and SOPs, and track QC metrics to support continuous improvement initiatives related to safety report quality and delivery.

The ideal candidate will have a strong attention to detail, excellent written and verbal communication skills in English, and proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates.

Required Skills and Qualifications
  • Master's degree and 1 to 3 years of pharmaceutical, biotech, or regulatory authority experience in a research and development setting OR Bachelor's degree and 3 to 5 years of pharmaceutical, biotech, or regulatory authority experience in a research and development setting OR Diploma and 7 to 9 years of pharmaceutical, biotech, or regulatory authority experience in a research and development setting
  • Strong understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e.g., PBRERs, DSURs, PADERs)
  • Excellent organizational and time management abilities, with the ability to manage competing priorities and strict deadlines while maintaining high-quality standards
  • Proficiency in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e.g., Veeva Vault, SharePoint)
Benefits

The successful candidate will contribute to the development and refinement of QC checklists, templates, and SOPs, and track QC metrics to support continuous improvement initiatives related to safety report quality and delivery.

Others

Ensuring Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes is a key responsibility of this role.

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