Senior Associate Safety Data Analyst

Amgen Inc; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Amgen Inc. is seeking a Sr. Associate - Safety Data Analyst to support pharmacovigilance activities, including generating outputs from the global safety system and helping configure data collection for trials.

You will work under limited direction to ensure timely, accurate safety data and reporting across PADER/PSUR/DSUR processes. The role emphasizes collaboration across teams, UAT participation, training development, and support for inspections, contributing to inspection readiness and data

Qualifications

• Masters degree in life sciences or related field.
• Bachelor's degree with 2 years directly related experience.
• High school diploma with 8 years directly related experience.
• Biotech/pharma industry experience preferred.

Responsibilities

• Generate outputs from the global safety system for periodic safety reports and audits.
• Support the implementation of safety system configurations and data collection.
• Participate in UAT and MSW mapping, and contribute to training and documentation.
• Assist in inspections/internal audits and ensure inspection readiness.

Skills

Safety systems knowledge

LifeSphere MultiVigilance/Argus

Cognos

Tableau

Data warehouse concepts

Data mining techniques

Software development lifecycle

Validation methodology

Regulatory pharmacovigilance

Clinical trial & PV processes

Audits/inspections experience

Cross-functional collaboration

Independent work

Education

Masters degree

Bachelor's degree + 2 years related

High school diploma + 8 years related

Tools

LifeSphere MultiVigilance

Argus

Cognos

Tableau

RAVE/Veeva EDC

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 escalation issues
• Pharmaceutical industry or health authority experience.
• Experience in supporting inspections or internal audits

Education Experience (Basic)

• Masters degree
• OR
• Bachelors 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