Sr. Associate Pharamocovigilance Operations

Amgen; Hyderabad; On-site; INR 1,000,000 - 1,400,000; Full time

Job summary

Amgen Inc. seeks a Safety Reporting professional to author and compile PASRs and related safety documents. You will coordinate cross-functional inputs, ensure timely delivery, and escalate risks to management. The role includes QC review, approvals, and distribution of reports to CROs and partners.

You will collaborate with Therapeutic Area scientists, maintain meticulous documentation, and stay updated on regulatory requirements to support global reporting obligations.

Qualifications

• Experience in authoring and compiling PASRs (Periodic Aggregate Safety Reports) and related safety reports.
• Ability to coordinate meetings with cross-functional stakeholders to ensure alignment.
• Strong focus on timelines, risk escalation, and adherence to regulatory guidelines.

Responsibilities

• Compile and author PASRs.
• Coordinate and schedule cross-functional meetings.
• Drive report timelines and escalate risks to leadership.
• Collaborate with stakeholders to collect safety contributions for PASR templates.
• Author safety content in collaboration with Therapeutic Area scientists.
• Perform peer QC of safety sections and manage review and approval workflows.
• Maintain records and documentation throughout the report process.
• Review and approve different report versions (blinded/unblinded, EU FDA, RoW).
• Distribute reports to CROs and business partners.
• Ensure adherence to guidelines and processes; develop KCIs and KPIs.

Skills

PASR authoring

Regulatory collaboration

Documentation management

Cross-functional coordination

Job description

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 elevate 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 .

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