Amgen is hiring for the Senior Associate Safety Data Analyst position in Hyderabad, India. This is an excellent opportunity for candidates interested in pharmacovigilance, drug safety databases, safety data analytics and clinical trial safety systems.
The Senior Associate Safety Data Analyst will support Amgen’s global pharmacovigilance activities by maintaining and improving global safety systems and delivering high-quality safety data outputs and visualizations. The role involves working with safety databases such as LifeSphere MultiVigilance and Argus, reporting and visualization tools such as Cognos and Tableau, and clinical trial databases including Rave and Veeva EDC.
Candidates with experience in the pharmaceutical or biotechnology industry, safety database support, pharmacovigilance reporting, clinical trial databases, UAT and safety-system configuration are particularly relevant for this opportunity.
Key Responsibilities
As a Senior Associate Safety Data Analyst at Amgen, you may be responsible for:
- Generating global safety system outputs for periodic safety reports, including PADER, PSUR and DSUR.
- Providing safety data outputs to support signal detection activities.
- Generating data required for audits, regulatory inspections and regulatory inquiries.
- Ensuring timely delivery of automated and scheduled safety data outputs.
- Performing quality checks and peer reviews of data outputs and routine system configurations.
- Collecting business requirements for routine pharmacovigilance safety data outputs.
- Supporting safety-system configurations, including reporting rule updates and product and study configurations.
- Developing or improving search strategies to ensure consistent safety data outputs.
- Supporting clinical study startup activities, including RAVE-Argus mapping UAT and Mapping Specifications Worksheet (MSW) approval.
- Participating in User Acceptance Testing (UAT) for safety-system changes.
- Contributing to technical solutions supporting safety systems and data outputs.
- Supporting training activities related to safety databases and tools.
- Assisting with the development of system-support quick reference guides.
- Performing delegated QPPV activities documented in the PV System Master File.
- Maintaining inspection readiness and supporting health authority inspections and internal process audits.
Qualification & Eligibility
According to the job description, candidates can qualify through any one of the following education and experience combinations:
Option 1: Master’s degree.
OR
Option 2: Bachelor’s degree + 2 years of directly related experience.
OR
Option 3: High school diploma/GED + 8 years of directly related experience.
Which Degrees May Be Relevant?
The posting specifies Master’s or Bachelor’s degree but does not specify a mandatory academic discipline. Based on the technical and pharmacovigilance responsibilities of the position, potentially relevant backgrounds may include:
B.Pharm, M.Pharm, Pharm.D, B.Sc/M.Sc Life Sciences, Biotechnology, Clinical Research, Pharmaceutical Sciences, Bioinformatics, Computer Science, Information Technology, Data Science, Engineering or other relevant disciplines, provided the candidate meets Amgen’s required education/experience criteria and possesses suitable safety-system/data skills.
Important: These degree examples are an interpretation of role relevance and are not an official exhaustive eligibility list from Amgen.
Required Knowledge & Skills
Candidates should have knowledge or understanding of:
- Pharmacovigilance and drug safety processes
- Clinical trial processes
- Global pharmacovigilance regulatory requirements
- Safety databases such as LifeSphere MultiVigilance and Argus
- Query and reporting tools such as Cognos and Tableau
- Data warehouse concepts
- Data mining techniques
- Software Development Life Cycle (SDLC)
- System validation methodologies
- Statistical analysis and interpretation of aggregate safety data
- Safety reporting and data-output processes
- Cross-functional collaboration
- Inspection and audit support
Candidates should also be capable of independently organizing, prioritizing and planning deliverables while proactively identifying and escalating issues.
Preferred Experience
Amgen lists the following as preferred:
- Work experience within the biotechnology or pharmaceutical industry
- Database support experience
- Understanding of clinical trial databases such as Rave or Veeva EDC
- Understanding of integrations between clinical trial databases and pharmacovigilance safety databases
- Pharmaceutical industry or health authority experience
- Experience supporting inspections or internal audits
Who Is a Strong Fit for This Role?
This Amgen Safety Data Analyst job may be particularly relevant to professionals currently working in:
- Pharmacovigilance / Drug Safety
- Safety Database Administration
- Safety Data Analytics
- Argus Safety Support
- Clinical Data Management
- Safety Systems
- PV Reporting and Analytics
- Clinical Safety Systems
- Safety Database Validation/UAT
Candidates who understand Argus or LifeSphere MultiVigilance, Rave/Veeva EDC, UAT, PSUR/DSUR/PADER reporting, Tableau/Cognos and global PV regulations may have particularly relevant profiles.
Is This Job Suitable for Freshers?
Potentially, depending on educational qualification.
The basic qualification explicitly states Master’s degree without listing a minimum number of years of experience alongside that route. Therefore, a candidate with a relevant Master’s degree may meet the stated basic education/experience threshold even without the two years required under the Bachelor’s-degree route.
However, the role is titled Senior Associate, and Amgen lists pharmaceutical/biotechnology industry experience, database support experience, clinical trial database knowledge and other specialized capabilities as preferred. Candidates should therefore assess their practical alignment with the required safety-system and data competencies before applying.
For candidates with a Bachelor’s degree, Amgen explicitly requires 2 years of directly related experience.
Why Consider This Amgen Opportunity?
This position provides exposure to multiple specialized areas within pharmacovigilance and clinical safety technology, including:
- Global pharmacovigilance systems
- Safety data analytics and reporting
- Periodic safety reporting
- Signal detection support
- Argus/LifeSphere safety databases
- Clinical-to-safety database integration
- Rave/Veeva EDC
- Safety-system configuration
- UAT and validation
- Regulatory inspections and audits
- Global safety data outputs
The combination of pharmacovigilance and technical data-system responsibilities can make this role particularly relevant for professionals looking to build expertise at the intersection of drug safety, clinical data and safety technology.
Salary
For structured-data and informational purposes, an estimated market range of approximately ₹7,00,000 to ₹14,00,000 per year may be considered for a specialized Senior Associate/Safety Data Analyst position in Hyderabad.
This is an editorial market estimate and is not an Amgen-provided salary figure. Actual compensation may differ depending on experience, skills, internal compensation structure and other factors.
How to Apply
