Periodic Report Specialist
Location: Hyderabad, India
Job ID: R-219472
Posted On: July 03, 2025
Work Type: On-Site | Full-Time
Department: Safety
About Amgen:
At Amgen, we combine cutting-edge science with deep commitment to patients. As a global biotechnology pioneer since 1980, we develop and deliver innovative therapies across Oncology, Inflammation, General Medicine, and Rare Disease. Every role at Amgen plays a part in improving lives through science—and this position is no exception.
Position Overview:
As a Periodic Report Specialist, you will be at the heart of Amgen’s global pharmacovigilance operations, contributing directly to the creation and coordination of Periodic Aggregate Safety Reports (PASRs). These include reports like DSUR, PBRER/PSUR, SSUR, PADER/PAER, Device PSURs, and local reports such as Korea PSUR, Brazil PSUR, and Colombia’s Clinical Research Annual Safety Report. Your role ensures timely delivery, compliance, and data integrity, aligning with global regulatory expectations.
Key Responsibilities:
Authoring & Compilation of PASRs:
Compile and author PASRs in collaboration with Therapeutic Area Safety Scientists.
Coordinate inputs from cross-functional teams and integrate contributions into reporting templates.
Ensure accuracy and clarity of safety content authored within each report.
Stakeholder Collaboration:
Schedule and facilitate meetings with internal and external stakeholders to maintain alignment and communication.
Manage timelines actively; identify potential risks or delays and escalate as necessary.
Collaborate with CROs and Business Partners for report distribution and coordination.
Quality Review & Documentation:
Conduct peer QC of authored safety sections and coordinate internal review processes.
Resolve reviewer comments and initiate final approval workflows.
Review and approve blinded/unblinded and region-specific versions of reports (e.g., EU, FDA, RoW).
Maintain accurate records, ensure regulatory compliance, and archive finalized documents.
Process Improvement & Monitoring:
Ensure adherence to SOPs, regulatory guidelines, and report standards.
Generate and track Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs) for PASR activities.
Participate in peer reviews using standardized checklists and QC processes.
Keep current with global regulatory updates, reporting trends, and technological improvements.
Literature Management (Optional):
Support literature surveillance and documentation activities, if required.
Qualifications:
Education:
Bachelor’s or Master’s degree in Life Sciences or Pharmacy
Experience:
Total Experience: 5–9 years
PASR-Specific Experience: Minimum of 2–3 years in periodic safety report writing
Required Competencies:
Solid understanding of pharmacovigilance regulations and periodic safety reporting (e.g., ICH E2C(R2))
Strong scientific and regulatory writing skills
High attention to detail with consistency in formatting and compliance
Excellent time and project management skills
Proficiency in Microsoft Office (Word, Excel) and safety documentation systems
Effective communication and stakeholder collaboration
Estimated Salary: ₹12–18 LPA (based on experience and industry benchmarks)
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