Senior Associate - Pharmacovigilance Operations

Amgen Inc; Hyderabad; On-site; INR 700,000 - 900,000; Full time

Job summary

Amgen Inc. in Hyderabad seeks a Pharmacovigilance Associate to support case intake, review and reporting aligned with global regulations. You will coordinate safety submissions to FDA/EMA, manage data-entry queries, and assist in training delivery, requiring strong attention to detail and MS Office skills.

The role involves liaising with local staff and vendors, performing case triage, and supporting inspection readiness and safety data reconciliation under PV processes.

Qualifications

• Understanding of global regulatory requirements for pharmacovigilance and safety reporting.
• Experience in case processing with focus on quality and timeliness.
• Attention to detail and ability to work with safety systems.

Responsibilities

• Support vendor oversight of all case intake and processing activities.
• Case review and escalation of case level issues.
• Support convention-related training delivery.
• Manage queries on Intake, triage, and data entry of ICRS.
• Reporting decision for submitting expedited safety reports to FDA/EMA.
• Ensure ICRS are evaluated for reporting in compliance with regulations and contracts.
• Report ICRS within time frames determined by regulations and contracts.
• Support BP reconciliation as required by safety agreement.
• Maintain inspection readiness and be representative for Health Authority Inspections and Internal Process Audits.
• Perform other duties as defined in SOPs or by supervisor.

Skills

Regulatory understanding

Attention to detail

Case processing experience

Safety system proficiency

Microsoft Office proficiency

Education

Bachelor's degree

Associates degree

High school diploma

Tools

Microsoft Office

Job description

Job Summary

Responsible for:

• Support vendor oversight of all case intake and processing activities
• Case review
• Escalation of case level issues
• Support convention-related training delivery
• Manage queries on Intake, triage, and data entry of ICRS
• Reporting decision for submitting all expedited safety reports to FDA/EMA
• Ensuring that individual ICRS are evaluated for reporting in compliance with regulations and contracts
• Reporting of ICRS within time frames determined by regulations and contracts
• Support BP reconciliation as required by safety agreement
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor.

Key Activities

• Support ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirements
• Perform case review
• Perform US case follow up activities
• Support the development and delivery of convention-related training material
• Review and respond to AE intake, triage, and submission queries in a timely fashion
• Initiate unblinding as requested
• Select cases for reporting to FDA/EMA and business partners based on detailed knowledge of legislation & contractual agreements
• Ensure compliance of reporting activities with timelines and criteria
• Interface with local office staff, vendors, and business partners for case processing as necessary
• Escalation of data entry issues identified
• Provide LAO E2B support (nullification, redistribution)
• Perform BP reconciliation as required by safety agreement
• Support the ICSR literature review process
• Support reportable event reconciliation for Amgen-sponsored clinical trials.
• Support other case processing functions as required.

Knowledge and Skills

• Understanding of global regulatory requirements for pharmacovigilance
• Familiarity with clinical development process
• Case processing experience with demonstrated high case level productivity and quality
• Attention to detail
• Proficiency in safety system
• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

Education & Experience (Basic)

Bachelors degree and 2 years of directly related experience OR Associates degree and 6 years of directly related experience OR High school diploma / GED and 8 years of directly related experience