Pharmacovigilance Operation Manager

Job Summary

• This position is responsible for performing routine weekly review of literature articles retrieved from Embase, Medline, and BIOSIS, which are the bibliographic databases used for Amgen’s global literature surveillance. The review supports signal detection for all Amgen portfolio of products and identification of individual case safety reports (ICSRs) for marketed products.
  
  

Key Activities and Responsibilities:

Literature Management Process -

• Monitor and manage the literature generic mailbox on a daily basis.
• Perform triage and categorization of incoming requests (e.g., search requests, queries, escalations, system issues).
• Ensure timely acknowledgment and routing to relevant stakeholders (e.g., reviewers, SMEs, safety physicians).
• Track and follow up on pending queries / unresolved items.
• Maintain mailbox logs / trackers for audit and oversight as applicable.
• Ensure adherence to defined timelines for responses.
• May perform review of literature results to determine if article contains ICSR relevant
• May assist with QC of Literature articles if required
• Determine whether full text article needs to be ordered and order them if further information is needed to confirm if citation meets criteria for ICSR or for signal detection
• Flag articles containing new aggregate safety information for TA Safety to perform secondary review
• Request Local Safety Officer to provide English translation if the article is not in English
• Notify business partner of articles received, if applicable
• Act as first-level support for literature-related systems (e.g., LSLI or equivalent platforms).
• Ensures Amgen remains in compliance and maintain high quality global literature review process
• Collaborate with cross function on process improvement initiatives
• Responsible for timely completion of review of weekly literature results
• Proactively propose - system and process improvement ideas
  
  

Support audits and inspections

• Extracting requested citations from literature citation management system
• Support audit and inspection deliverables, including but not limited to information requests and response QC.
  
  

Support updates of search strings based on:

• Product lifecycle changes
• Safety signals or emerging risks, Regulatory / SOP updates.
• Maintain version control and documentation of search strategies.
• Participate in technology and process improvement projects related to literature surveillance
  
  

Technology:

• Manager User access / permissions (where applicable), System queries and issue logging, Coordinate with IT / system support teams for issue resolution and escalation.
• Ensure proper data entry, tracking, and reconciliation within systems.
• Support system UAT / validation activities when required.
• Participate in technology projects related to literature surveillance
  
  

Training and Mentoring

• Provide process overview and literature review system training to new hires and junior staff
• Collaborate with local offices to ensure seamless local and global literature process handoff
• Provide process and system training to new hires and mentor junior staff
  
  

Knowledge And Skills

• Ability to identify literature articles containing ICSR criteria or aggregate safety findings supporting signal detection
• Ability to order full text articles where needed
• Ability to receive feedback from Case Management and TA Safety and optimize quality of literature review
• Demonstrate knowledge of global aspects of pharmacovigilance
• Strong knowledge of processes and global regulations for pharmacovigilance and literature surveillance
• Ability to effectively manage competing priorities and timelines
• Strong knowledge of literature citation management systems and platform used to configure search strategies
• Experience in use of AI and prompts would be useful
  
  

Education & Experience (Basic)

Master’s with 8+yrs of experience in Pharma domain with atleast

5 years of Literature screening/Review or relevant Safety experience with 1+year of relevant QC experience

• Education & Experience (Preferred)
  
  

Health Care Professional with minimum 8 years of relevant work experience including 5 years of experience in literature review and 2 years of people manager experience