Career Category

Engineering

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 escalate 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

.

📌 Senior Associate Safety Data Analyst (Hyderabad)
🏢 AMGEN
📍 Hyderabad