Sr. Associate Pharamocovigilance Operations

Biopharma Careers; Hyderabad; On-site; INR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Bilingual/Multinational exposure

Job summary

Biopharma Careers is seeking a Safety PASR writer to support the authoring, compilation and peer review of periodic safety reports in alignment with global regulatory requirements. You will collaborate with cross-functional teams to collect inputs, draft safety content and manage approval workflows.

The role emphasizes end-to-end documentation, timely delivery and maintaining current knowledge of regulatory guidelines and industry standards in a Hyderabad, India setting.

Qualifications

• Experience authoring PASRs and related safety reports (DSUR, PSUR, PBRER, SSUR) is preferred.
• Ability to coordinate cross-functional teams and align timelines.
• Proficiency in safety content development and regulatory review processes.

Responsibilities

• Coordinate and schedule meetings with cross-functional stakeholders to ensure collaboration.
• Drive report timelines and escalate risks or delays to team leads or management.
• Collaborate with stakeholders to collect PASR contributions and compile into PASR template.
• Author safety content for PASRs in collaboration with Therapeutic Area Safety scientists.
• Perform peer QC of safety sections, coordinate review and manage approval workflows.
• Maintain and archive accurate records throughout the report process.
• Review and approve published report versions (blinded, unblinded, EU FDA, ROW).
• Manage report distribution to CROs and business partners.
• Ensure adherence to timelines, regulatory guidelines and applicable standards.
• Peer review safety reports within established timelines using checklists.

Skills

Regulatory writing

Cross-functional collaboration

Document management

Quality QC

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 escal 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.