Sr Assoc Pharmacovigilance Operations

Amgen Technology; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amgen Technology in Hyderabad is seeking a Pharmacovigilance Case Processing Specialist to support vendor oversight and case intake, review, and data entry in line with regulatory contracts. The role involves escalation of issues, training delivery, and ensuring timely reporting to FDA/EMA.

You will collaborate with local staff and partners, perform US case follow ups, participate in inspections, and help maintain inspection readiness under SOPs.

Qualifications

• Bachelor's degree with 2 years of related experience.
• Associates degree with 6 years of related experience.
• High school diploma or GED with 8 years of related experience.

Responsibilities

• Support ICSR processing to ensure high-quality cases in a timely manner.
• Perform case review.
• Perform US case follow up activities.
• Provide LAO E2B support (nullification, redistribution).
• Support reportable event reconciliation for Amgen-sponsored clinical trials.

Skills

Understanding of global regulatory

Familiarity with clinical development

Case processing experience high-level

Attention to detail

Proficiency in safety system

Microsoft Suite

Education

Bachelor's degree with 2 years related experience

Associates degree with 6 years related experience

High school diploma / GED with 8 years related experience

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