Periodic Report Safety Qc Reviewer

7 days ago

Hyderabad Telangana, India Amgen Full time

The primary responsibility of this role is to perform quality control reviews of of Amgen’s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met.
Key Responsibilities:

- Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements.
- Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases.
- Collaborate 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 SOPs to ensure consistent review practices.
- Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery.

Basic Qualifications and Experience:

- Total experience: 5-9 years
- At least 2-3 years in QC
- Bachelor’s or Master’s degree in Life Sciences or Pharmacy

  • Periodic Report Safety QC Reviewer

    1 day ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    The primary responsibility of this role is to perform quality control reviews of of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER),...

  • Periodic Report Specialist

    2 weeks ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Periodic Report Specialist Career CategorySafety Job Description This position plays a role in the authoring, compilation and peer review of Amgen's Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update...

  • Periodic Report Specialist

    1 day ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    This position plays a role in the authoring, compilation and peer review of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device...

  • Periodic Report Specialist

    1 week ago

    Hyderabad, Telangana, India Amgen Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Career CategorySafetyJob DescriptionThis position plays a role in the authoring, compilation and peer review of Amgen's Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug...

  • QA & QC Reviewer

    7 days ago

    Hyderabad, Telangana, India avasya lab Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionWe suggest you enter details here.Role DescriptionThis is a full-time, on-site role for a QA & QC Reviewer located in Hyderabad, India. The QA & QC Reviewer will be responsible for reviewing, overseeing, and ensuring the quality of products and processes. Day-to-day tasks will include performing quality control checks, conducting quality...

  • Medical Safety Writer- Aggregate Reports

    2 days ago

    Hyderabad, India Novartis Full time

    2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety. - Your responsibilities include, but are...

  • Qc Technician

    1 week ago

    Hyderabad, Telangana, India Vian Properties Full time

    Greetings All **Job Title: QC Lab Technician (Construction)** **Location**: Kollur Site, Hyderabad **Department**: Quality Control **Reports To**: QA/QC Engineer / Project Manager **Job Summary**: Responsible for conducting material testing and quality checks for construction materials at site and lab, ensuring compliance with industry standards and...

  • Literature Review Specialist

    16 hours ago

    Hyderabad, Telangana, India Amgen Full time

    Career Category Safety Join Amgen s Mission of Serving Patients At Amgen if you feel like you re part of something bigger it s because you are Our shared mission to serve patients living with serious illnesses drives all that we do Since 1980 we ve helped pioneer the world of biotech in our fight against the world s toughest diseases With our focus on four...

  • QC Reviewer/Assistant Manager/Manager

    1 week ago

    Hyderabad, Secunderabad, India Jansat Labs Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    We are seeking a dynamic and experienced Quality Control (QC) Manager to lead and manage QC operations, ensuring that products and processes meet stringent quality and regulatory requirements. The ideal candidate will possess deep technical expertise, a strong leadership background, and a commitment to data integrity and continuous improvement within the...

  • QA Reviewer[4+],qc[2+](Pharma Industry)

    2 weeks ago

    Hyderabad, Telangana, India Futurelife4u Full time

    Hi, **1)QA reviewer** **2)QC [LCMS]** for reputed pharma company. **Eligibility**: 2)Good work experience in QA,QC Deportments. 3)Good Attitude. **salary**:16k-45k. **Location**:Hyderabad. Pay: ₹16,000.00 - ₹45,000.00 per month Schedule: - Rotational shift **Education**: - Master's (preferred) Work Location: In person **Speak with the...