Soterius has announced an opening for Senior Associate – Pharmacovigilance Technology Solutions for its Noida location. This full-time opportunity is designed for professionals with 2–4 years of experience who want to build their careers at the intersection of pharmacovigilance, drug safety, safety databases, GxP technology and computer system validation.
The position combines traditional pharmacovigilance responsibilities such as ICSR case processing and adverse drug reaction review with technology-focused activities including system configuration, validation, upgrades, change requests, release management and technology deployment.
Soterius Job Overview
| Particular | Details |
|---|---|
| Company | Soterius |
| Position | Senior Associate – Pharmacovigilance Technology Solutions |
| Location | Noida, Uttar Pradesh |
| Employment Type | Full-Time |
| Experience | 2–4 Years |
| Industry | Pharmacovigilance / Drug Safety |
| Function | PV Technology Solutions |
| Posted | August 25, 2026 |
About the Role
The Senior Associate – Pharmacovigilance Technology Solutions will support drug safety and pharmacovigilance operations while also contributing to the development, implementation and lifecycle management of technology solutions.
The selected professional will work with safety and medical information databases, internally developed systems and other GxP-relevant technology solutions.
This makes the Soterius Senior Associate opportunity particularly relevant for pharmacovigilance professionals seeking exposure beyond conventional case processing and into PV systems, validation, configuration and technology operations.
Key Responsibilities
The Senior Associate will be responsible for:
- Supporting drug safety and pharmacovigilance activities according to business requirements.
- Recording and reviewing adverse drug reactions (ADRs) in applicable safety databases.
- Processing post-marketing and clinical trial safety reports according to regulatory standards and client procedures.
- Maintaining high standards of accuracy and quality during safety data processing.
- Supporting development and deployment of assigned technology solutions.
- Providing administrative, implementation and operational support for technology systems.
- Supporting system validation, upgrades, bug fixes and change requests.
- Providing support throughout the technology product lifecycle.
- Communicating with internal and external stakeholders when required.
- Ensuring effective functioning of assigned pharmacovigilance projects.
- Supporting ICSR case processing and maintaining compliance with applicable regulations, guidelines and client agreements.
- Taking ownership of assigned projects and ensuring adherence to quality standards and timelines.
- Managing quality, compliance and documentation across assigned projects.
- Escalating concerns that could affect work quality or operational performance.
- Working continuously with stakeholders to maintain regulatory and contractual compliance.
- Training and mentoring team members when required.
- Supporting and representing the function during audits and regulatory inspections.
- Authoring and reviewing SOPs and other departmental documentation.
- Supporting deployments of Soterius technology systems for internal and external users.
- Working with hosted safety databases and medical information databases.
- Supporting internally developed and other GxP-relevant technology solutions.
- Performing technology system configuration activities.
- Supporting validation, release management and associated documentation.
- Providing computer system validation support during customer and regulatory audits or inspections.
Qualifications & Eligibility
The supplied Soterius job posting does not specify an exact educational qualification.
Based on the pharmacovigilance and drug-safety responsibilities of the position, relevant educational backgrounds may include B.Pharm, M.Pharm, Pharm.D, B.Sc/M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research, Nursing, or other relevant healthcare/life-science qualifications.
However, these degrees are indicative based on the nature of the position and should not be considered officially stated eligibility requirements unless confirmed by Soterius.
Experience Required
Candidates should have 2–4 years of relevant experience.
Professionals with experience in one or more of the following areas may be particularly relevant:
Pharmacovigilance | Drug Safety | ICSR Case Processing | Safety Databases | Clinical Trial Safety | Post-Marketing Safety | GxP Systems | Computer System Validation | System Configuration | Validation Documentation | Change Requests | Release Management | SOPs | Audits & Inspections
Skills Relevant to the Role
Candidates should ideally have knowledge or practical exposure to:
- Pharmacovigilance and drug safety operations
- ICSR case processing
- Adverse Drug Reaction processing and review
- Clinical trial and post-marketing safety reports
- Safety databases
- Regulatory compliance
- GxP technology systems
- Computer System Validation (CSV)
- System implementation and configuration
- System validation and deployment
- Change control and change requests
- Release management
- SOP authoring and review
- Quality and compliance documentation
- Audit and inspection support
- Stakeholder management
- Project ownership
- Training and mentoring
Why This Role Stands Out
The Soterius Pharmacovigilance Technology Solutions job offers an opportunity to combine pharmacovigilance domain expertise with technology and GxP system experience.
Instead of focusing exclusively on ICSR processing, the position provides exposure to the broader lifecycle of pharmacovigilance technology, including implementation, validation, configuration, deployment, upgrades, release management and audit support.
This combination can be particularly valuable for PV professionals interested in developing careers in PV systems, safety database administration, GxP technology, CSV or pharmacovigilance technology consulting.
How to Apply
