Sr Assoc Pharmacovigilance Operations

Amgen SA; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Amgen SA seeks a pharmacovigilance professional to oversee ICSR processing and timely reporting to global regulators. You will review cases, handle US follow-ups, and help train teams on convention-related processes.

You will liaise with vendors and local staff to ensure regulatory compliance, data integrity, and efficient issue resolution within Amgen’s safety programs.

Qualifications

• Understanding of global regulatory requirements for pharmacovigilance.
• Familiarity with clinical development process.
• Case processing experience with high productivity and quality.
• Attention to detail and accuracy in data handling.
• Proficiency with safety systems and standard operating procedures.

Responsibilities

• Support ICSR processing to ensure high-quality cases within regulatory timelines.
• Perform case review and US case follow-up activities.
• Develop and deliver convention-related training materials.
• Review AE intake, triage, and submission queries promptly.
• Initiate unblinding when requested and reportable event reconciliation.
• Select cases for reporting to FDA/EMA per contracts and legislation.
• Ensure compliance of reporting activities with timelines and criteria.
• Interface with local staff, vendors, and partners for case processing.
• Escalate data entry issues and provide LAO E2B support as needed.
• Assist BP reconciliation and safety agreement requirements.
• Support literature review and reporting for Amgen-sponsored trials.

Skills

Regulatory pharmacovigilance

Clinical development understanding

High-quality case processing

Attention to detail

Safety system proficiency

Microsoft Office

Education

Bachelor’s degree 2+ years related experience

Associate’s degree 6+ years related experience

High school diploma / GED 8 years related experience

Tools

Microsoft Word

Excel

PowerPoint

Project

Outlook

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 IC…​
• Reporting decision for submitting all expedited safety reports to FDA/EMA
• Ensuring that individual ICSR are evaluated for reporting in compliance with regulations and contracts
• Reporting of ICSR 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)

Bachelor’s degree and 2 years of directly related experience

OR

Associate’s degree and 6 years of directly related experience

OR

High school diploma / GED and 8 years of directly related experience