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Amgen
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Sr. Associate Pharmacovigilance Operations

Sr. Associate Pharmacovigilance Operations

Amgen

5 years

0 Lacs

Hyderabad Telangana India

Posted:1 month ago| Platform:

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Skills Required

pharmacovigilance reports development report risk evaluation research compliance writing documentation schedule collaboration drive content qc resolve archive rest metrics management

Work Mode

On-site

Job Type

Full Time

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

Basic Qualification and Experience:

Master’s degree or Bachelor's degree with 5 years of experience

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Sr. Associate Pharmacovigilance Operations