Pharmacovigilance Operations – PASR Authoring & Safety Reporting
Company: Amgen
Location: Hyderabad, Telangana, India
Work Location: On-Site
Department: Safety / Pharmacovigilance Operations
Employment Type: Full-Time
Job ID: R-246911
Experience Required: 3–7 Years (estimated based on role complexity and PASR ownership responsibilities)
Salary Package
Expected CTC: ₹10 LPA – ₹22 LPA (Estimated market range based on pharmacovigilance aggregate reporting experience, PASR authoring skills, regulatory knowledge, and pharmaceutical industry exposure. Actual compensation may vary.)
Job Summary
The Pharmacovigilance Operations Specialist is responsible for supporting the end-to-end preparation, authoring, compilation, quality review, and submission readiness of global Periodic Aggregate Safety Reports (PASRs).
The role focuses on regulatory-compliant safety reporting activities including DSUR, PBRER, PSUR, PADER/PAER, Device PSUR, and country-specific safety reports. The position requires collaboration with Safety Scientists, Regulatory Affairs, Clinical teams, CROs, and business partners to ensure accurate, high-quality, and timely delivery of safety reports.
Key Responsibilities
Periodic Aggregate Safety Report (PASR) Management
Support compilation and authoring of global aggregate safety reports, including:
Development Safety Update Reports (DSUR)
Periodic Benefit Risk Evaluation Reports (PBRER)
Periodic Safety Update Reports (PSUR)
Semi Annual Safety Update Reports (SSUR)
Periodic Adverse Drug Experience Reports (PADER/PAER)
Device PSUR
Country-specific safety reports:
Korea PSUR
Brazil PSUR
Colombia Clinical Research Annual Safety Report
Ensure reports are prepared according to:
Global regulatory requirements
Company procedures
Regulatory guidelines
Applicable reporting standards
Report Authoring & Cross-Functional Coordination
Coordinate meetings with cross-functional stakeholders to ensure alignment on report deliverables.
Manage PASR timelines, milestones, and deliverables.
Identify potential risks, delays, and issues and escalate appropriately.
Collaborate with:
Therapeutic Area Safety Scientists
Regulatory Affairs teams
Clinical Development teams
Medical reviewers
External CROs and business partners
Collect safety contributions from stakeholders and compile content into PASR templates.
Author safety sections of aggregate reports with scientific accuracy and regulatory compliance.
Quality Control & Review Activities
Perform peer review and quality checks of PASR sections.
Review safety content for:
Accuracy
Completeness
Consistency
Regulatory compliance
Coordinate Amgen review cycles and manage resolution of comments.
Initiate and track approval workflows.
Apply quality review checklists and established procedures.
Review final published report versions, including:
Blinded reports
Unblinded reports
EU reports
FDA reports
Rest of World reports
Documentation & Compliance Management
Maintain accurate documentation and audit trails throughout the reporting lifecycle.
Archive finalized reports and supporting documentation.
Manage report distribution to:
Contract Research Organizations (CROs)
Business Partners (BPs)
Relevant stakeholders
Ensure compliance with:
Pharmacovigilance procedures
Regulatory timelines
Quality standards
PV Metrics & Process Improvement
Generate and maintain PASR performance metrics, including:
Key Compliance Indicators (KCIs)
Key Performance Indicators (KPIs)
Monitor reporting timelines and operational performance.
Maintain updated knowledge of:
Regulatory guidelines
Industry standards
Pharmacovigilance best practices
Technological advancements
Literature Management Support
Support literature management activities as required.
Assist with safety literature review processes.
Ensure relevant safety information is appropriately captured and documented.
Required Qualifications
Bachelor’s or Master’s degree in:
Pharmacy
Life Sciences
Medicine
Related healthcare discipline
Experience in Pharmacovigilance operations within:
Pharmaceutical companies
Biotechnology organizations
CRO environments
Required Experience
Experience in aggregate safety reporting activities.
Hands-on experience with:
DSUR preparation
PBRER/PSUR authoring
PADER/PAER reporting
Safety document review
Experience coordinating cross-functional safety deliverables.
Understanding of global pharmacovigilance regulations.
Required Skills
Strong knowledge of aggregate report lifecycle management.
Good understanding of:
ICH E2C guidelines
ICH safety reporting requirements
GVP principles
Global regulatory expectations
Strong medical writing and scientific documentation skills.
Excellent attention to detail and quality focus.
Strong project coordination and timeline management skills.
Ability to manage multiple priorities within strict deadlines.
Strong stakeholder communication and collaboration skills.
Proficiency in Microsoft Office applications, especially:
Word
Excel
PowerPoint
Preferred Skills
Experience with global regulatory submissions.
Experience working with health authority reporting requirements.
Knowledge of safety databases and pharmacovigilance systems.
Experience supporting regulatory inspections and audits.
Familiarity with literature surveillance processes.
Experience generating PV compliance metrics.
Career Opportunity at Amgen
Opportunity to work on global pharmacovigilance reporting activities.
Exposure to complex safety programs across multiple therapeutic areas.
Collaboration with global safety experts and regulatory teams.
Development opportunities in aggregate reporting, safety surveillance, and PV leadership roles.
Contribution to ensuring patient safety through high-quality regulatory reporting.
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Frank Scottile Blvd |Missouri :
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