Sr Assoc Pharmacovigilance Operations

Amgen; Hyderabad; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Amgen in Hyderabad, India is seeking a PV operations professional to manage case intake, processing, and review activities. The role focuses on ensuring regulatory-compliant ICSSRS reporting and timely escalation of issues within the pharmacovigilance framework.

The job involves training support, QPPV-delegated activities, data-entry oversight, and collaboration with vendors and local staff to maintain inspection readiness.

Qualifications

• Bachelor's degree with 2 years of related experience or equivalent.
• Experience in pharmacovigilance or ICSR processing is preferred.
• Ability to follow regulatory requirements and contracts.

Responsibilities

• Support vendor oversight of case intake and processing activities.
• Perform case reviews and escalate issues as needed.
• Support training material development and delivery.
• Respond to intake, triage, and data entry queries in a timely manner.
• Ensure reporting to FDA/EMA within regulatory timelines.

Skills

Regulatory knowledge

Attention to detail

Case processing experience

Safety system proficiency

Microsoft Office proficiency

Education

Bachelor's degree with 2 years related experience

Associate's degree with 6 years related experience

High school diploma / GED with 8 years related experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Outlook

Job description

• 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 ICSSRS
• Reporting decision for submitting all expedited safety reports to FDA/EMA
• Ensuring that individual ICSSRS are evaluated for reporting in compliance with regulations and contracts
• Reporting of ICSSRS 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.

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