Sr. Associate Pharamocovigilance Operations

Amgen Inc. (IR); Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amgen in Hyderabad seeks a Sr. Associate Pharmacovigilance Operations to support the authoring and compilation of PASRs, including DSUR and PSUR. You will coordinate cross-functional stakeholders, drive timelines, and ensure accurate documentation and timely submission to CROs and BPs.

You will collaborate with safety scientists to draft content, perform QC, and oversee the approval workflows, maintaining adherence to regulatory guidelines and industry standards.

Responsibilities

• Compile and author PASRs (DSUR, PSUR, PADER/PAER, etc.).
• Coordinate meetings with cross-functional stakeholders to ensure collaboration.
• Drive timelines and escalate risks or delays to leads/management.
• Gather PASR contributions and compile into templates with partners.
• Author safety content with Therapeutic Area Safety scientists.
• Peer QC of safety content and manage review/approval workflows.
• Maintain records and documentation throughout the report process.
• Review and approve published PASR versions (blinded/unblinded/EU FDA/Rest of World).
• Distribute reports to CROs and Business Partners.
• Ensure adherence to timelines, guidelines, styles and processes.
• Peer review of PASRs within timelines using checklists.
• Maintain knowledge of regulatory guidelines and industry standards.
• Generate PASR metrics: KCIs and KPIs.
• May assist with Literature Management activities as required.

Skills

PASR writing

Cross-functional collaboration

Timeline management

Quality control

Regulatory familiarity

Job description

## Sr. Associate Pharamocovigilance OperationsApplyremote type: On Sitelocations: India - Hyderabadtime type: Full timeposted on: Posted Todayjob requisition id: R-246911## **Career Category**Safety## ## **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 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. In compliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met. **Key Responsibilities: Compilation and authoring of PASRs** • Coordinate and schedule all meetings with cross-functional stakeholders to ensure effective collaboration and alignment • Drive report timelines and escalate risks or delays to team leads or management • Collaborate with cross-functional stakeholders and external business partners to collect PASR contributions and compile into PASR template. • Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists • Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows. • Maintain and archive accurate records and documentation throughout the report process. • Review and approve published report versions (i.e. blinded, unblinded, EU FDA, Rest of World). • Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs) • Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes • Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists • Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards • Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).**Literature Management Process**• May assist with Literature Management activities as required.### About Us**Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.****Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.****For more information, visit www.amgen.com****and follow us on www.twitter.com/amgen**