Senior Associate Safety Data Analyst

Amgen; India; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Amgen is seeking a Sr. Associate - SDA to support pharmacovigilance data outputs and the global safety system. You will assist in configuring Datamart, collecting business requirements, and participating in UAT for system changes.

The role involves generating outputs for periodic safety reports, performing signal detection, and supporting audits/inspections, with a focus on data quality and regulatory compliance.

Qualifications

• Master's degree or equivalent with relevant pharmacovigilance background.
• Bachelor's degree with at least 2 years of directly related experience; or high school diploma with 8 years of related experience.

Responsibilities

• Generate outputs from the global safety system for periodic safety reports (PADER, PSUR, DSUR).
• Support changes to the global safety system and Datamart configurations.
• Perform quality checks and peer review of data outputs and system configurations.
• Assist in collecting business requirements for routine safety data outputs.
• Participate in user UAT and validation activities for safety system changes.
• Support inspections and internal audits related to PV systems.

Skills

Safety systems

Data warehouse

SDLC

Regulatory knowledge

Clinical trials

Statistics

Cross-functional collaboration

Independent worker

Audit readiness

Education

Master's degree

Bachelor's + 2 years related experience

High school diploma + 8 years related experience

Tools

Cognos

Tableau

Job description

Career Category

Engineering

Job Description

Group Purpose:

This group supports pharmacovigilance activities through the maintenance, development and continuous improvement of the global safety system and the provisioning of high-quality data outputs/visualizations.

Job Summary:

• Support changes to the global safety system and associated Datamart
• Support the implementation of global safety system configurations
• Support accurate clinical trial safety data collection in the global safety system

Key Activities:

With limited direction from Sr. Manager-Safety Data Analyst (SDA), the Sr. Associate - SDA may perform the following activities:

• Generate outputs from the global safety system in support of periodic safety reports (e.g., PADER, PSUR, DSUR)
• signal detection
• audits, inspections and regulatory inquires
• Ensure delivery of automated/scheduled safety data outputs
• Perform Quality Checks/Peer Review as needed for data outputs and routine system configurations
• Participate in collecting business requirements for routine safety data outputs
• Participate in the implementation of routine system configuration including reporting rule updates, product and study configuration
• Augment and/or define search strategies in collaboration with leads to ensure consistent data outputs
• Support study startup activities such as RAVE-Argus mapping User Acceptance Testing (UAT), Mapping Specifications Worksheet (MSW) approval
• Participate in user UAT of safety system changes
• Contribute to the development and maintenance of technical solutions to support safety system and data outputs
• Participate in the development and delivery of training related to safety database and tools
• Assist in the development of system support related quick reference guides.
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Support Authority Inspection and Internal Process Audits within the remit of role and responsibility

Knowledge and Skills:

• Knowledge of safety systems (LifeSphere MultiVigilance platform/Argus) as well as query and reporting tools e.g. Cognos, Tableau
• Understanding of data warehouse concepts and data mining techniques
• Understanding of software development lifecycle and development standards, including validation methodology
• Understanding of global regulatory requirements for pharmacovigilance and safety reporting
• Understanding of Clinical Trial and Pharmacovigilance Processes
• Familiarity with statistical analysis and interpretation of aggregate safety data
• Organization, prioritization, planning and measurement of work deliverables
• Ability to build relationships and work cross-functionally
• Work independently and proactively; recognize and escape issues
• Pharmaceutical industry or health authority experience.
• Experience in supporting inspections or internal audits

Education & Experience (Basic):

• Master's degree
• Bachelor's degree and 2 years of directly related experience
• High school diploma / GED and 8 years of directly related experience

Education & Experience (Preferred):

• Work experience in biotech/pharmaceutical industry
• Database support work experience
• Understanding of clinical trial databases such as Rave/Veeva EDC
• Understanding of integration between clinical trial databases and safety databases