Senior Associate - Safety Data Analyst

Amgen Technology Private Limited; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amgen Technology Private Limited in Hyderabad, India, seeks a Senior Associate Safety Data Analyst to support pharmacovigilance data outputs, Datamart and safety system configurations.

You will generate PSUR/DSUR outputs, perform quality checks, assist in UAT and training, and help prepare for inspections within a cross-functional team.

Qualifications

• Master’s degree in a relevant field or equivalent directly related experience.
• Bachelor’s degree with 2 years related experience or High school diploma with 8 years related experience.

Responsibilities

• Generate outputs for periodic safety reports (PSUR/DSUR) and audits.
• Ensure automated/scheduled safety data outputs.
• Perform quality checks/peer review for data outputs and configurations.
• Gather business requirements for routine safety data outputs.
• Implement routine system configurations including reporting rules and product/study configurations.
• Augment/search strategies to ensure consistent data outputs.
• Support study startup activities (UAT, MSW approval) for safety systems.
• Participate in user UAT of safety system changes.
• Develop and maintain technical solutions to support safety data outputs.
• Deliver training related to safety databases and tools.
• Assist in creating quick reference guides; maintain inspection readiness.
• Support inspections and internal process audits.

Skills

Data analysis

Data mining

DWH concepts

SDLC

Pharmacovigilance

Cross-functional

Independent work

Inspections

Education

Master’s degree

Bachelor’s +2 years

High school diploma / GED

Tools

Argus

LifeSphere MultiVigilance

Cognos

Tableau

Job description

Senior Associate Safety Data Analyst

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

• Generate outputs from the global safety system in support of periodic safety reports (e.g., PADER, PSUR, DSUR), signal detection audits, inspections and regulatory inquiries
• 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 OR Bachelor’s degree and 2 years of directly related experience OR 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 .

Experience Level

Mid Level