Senior Manager - Pharmacovigilance Operations

Group Purpose

Group is accountable for global literature surveillance activities for all Amgen portfolio of products. Responsible for performing the weekly review of literature articles for signal detection and identification of safety reports.

Job Summary

This role provides end-to-end strategic, operational, and governance oversight of global literature surveillance activities across the Amgen portfolio. The Sr Manager is accountable for ensuring regulatory compliance, driving operational excellence, and enabling strategic transformation of literature review processes, including screening, quality management, search strategy governance, systems, and ancillary operations.

This position may perform 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.

The role serves as the single point of accountability for quality, processes and innovation, while partnering with global stakeholders to drive scalable, compliant, and future-ready literature operations.

Key Activities

Key Responsibilities:

1. Literature Management Process

• Supervision of a team of Literature Specialists, responsible for performing routine weekly review of literature articles retrieved from Embase, Medline, and BIOSIS, 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.

2. Establish and maintain governance frameworks for:

• Literature review, Search strategy management, Quality and compliance oversight, Systems and operational support, Participate in decision authority for high-impact operational, quality, and compliance matters.

• Ensure consistent achievement of internal/external SLA/TAT commitments.

3. Oversee:

• Workflow management (via Leads), Mailbox operations, Ancillary activities (search strings, systems, coordination).

Monitor and optimize:

• Queue volumes and ageing, Productivity and utilization, Vendor performance,

Oversee quality framework, including:

• QC processes and error monitoring, CAPA management and closure ,Trend analysis and risk mitigation

• May perform retrospective quality checks on the quality of the literature review performed by team

• Business process owner for global literature review process and literature management systems.

4. Drive initiatives to:

• Improve throughput and cycle time, optimize cost and resource utilization

• Reduce manual effort through automation.

• Identify and implement process simplification and standardization opportunities.

5. Lead cross-functional improvement programs

• Represent literature operations in global governance forums and leadership discussions.

• Lead and develop a multi-tier team (Associates, Specialists, QC, Leads).

6.Ensure:

• Appropriate training and qualification of staff, Succession planning and capability building, Foster a high-performance, quality-focused culture.

• Drive adoption of new tools, technologies, and ways of working.

• Maintains quality metrics to ensure quality of literature review performed by team

• Responsible for or delegate responsibilities of triaging queries from case management and Therapeutic Area Safety

• Oversight of literature review team responsible for routine review of literature articles as part of global literature surveillance process

• Identifies process gaps and proposes process improvement solutions

• Collaborate with local offices to ensure seamless local and global literature process handoffs

• Participate in technology and process improvement projects related to literature surveillance

• Responsible for ownership of literature review process related procedures, training documents, deviation management, and audits/inspections

Inspection Readiness:

• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

• Support audit and inspection deliverables, including but not limited to information requests and response QC.

Knowledge and Skills

• Extensive people management experience

• Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment

• Understands and interprets data/information and its practical application

• Excellent English written/oral communication, and strong time and project management skills

• strategic mindset, attention to detail, and the ability to work collaboratively across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations.

• Demonstrate knowledge of global aspects of pharmacovigilance

• Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting

• Ability to effectively manage competing priorities and timelines

• Strong leadership skills, independence, networking and influencing skills

• Computer literate: knowledge of MS work, PowerPoint, Adobe Acrobat, MS Excel, SharePoint and Document Management Systems e.g. Veeva Vault

• Strong knowledge of literature citation management systems and platform used to configure search strategies

• Ability to receive feedback from Case Management and Therapeutic Area Safety to optimize quality of literature review

• Experience in use of AI and prompts would be useful

Education & Experience (Basic)

Bachelor’s or Master's degree and 14 years of pharmaceutical, biotech or regulatory authority experience or relevant experience in a research and development setting

Education & Experience (Preferred)

Health Care/Life Sciences Professional with minimum 12 years of relevant work experience including 5 years of experience in people management