1074 Amgen Technology Pvt Ltd. logo

Sr Assoc Pharmacovigilance Operations

1074 Amgen Technology Pvt Ltd.

RemoteFull timeMid levelPosted today
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About the role

Career Category

Safety

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

.

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