Job Title
Pharmacovigilance Safety Systems Specialist (PV Systems Support)
Experience: 2+ Years
Education: Life Sciences / IT / Computer Science (or equivalent experience)
Work Environment: Office or Remote
Job Overview
This role supports the implementation, configuration, migration, and maintenance of Pharmacovigilance (PV) safety systems.
You will provide technical and operational support for drug safety systems used in clinical and post-marketing safety activities, ensuring compliance, quality, and system integrity.
The role also involves supporting clients and internal teams with system-related processes in a safe, efficient, and cost-effective manner, aligned with regulatory and safety standards.
Key Responsibilities
1. Safety System Implementation & Configuration
Support implementation, configuration, and migration of PV safety systems
Perform project-specific system configurations
Maintain and update system configurations based on requirements
2. Reporting & Data Extraction
Develop standard and ad-hoc reports from safety systems
Perform data extraction activities such as:
PSUR (Periodic Safety Update Reports)
DSUR (Development Safety Update Reports)
6-month safety listings
3. Data Migration & System Validation
Participate in system data migration activities
Document migration processes and outcomes
Perform User Acceptance Testing (UAT) and complete documentation
4. System Support & Issue Management
Manage ticketing system for issue tracking and resolution
Escalate system issues when required
Monitor system mailboxes for failures and resolve them promptly
Respond to user queries and support requests
5. Training & Change Management
Support system training for end users and sponsors
Train team members on technical and functional system aspects
Assist in system change management activities
6. Compliance & Quality Assurance
Ensure adherence to SOPs and regulatory requirements
Maintain compliance with current pharmacovigilance regulations
Deliver high-quality outputs consistently
7. Documentation & System Maintenance
Maintain system configuration documentation
Ensure accurate tracking of system changes
Support validated document management systems
8. Collaboration & Team Support
Work as part of PV systems and technical teams
Provide peer support when required
Support cross-functional communication between stakeholders
Required Qualifications
Degree in Life Sciences or IT/Computer Science
OR
Equivalent relevant professional experience
Experience Required
Minimum 2 years in:
Drug safety systems (e.g., Argus, ARISg, Veeva or equivalent)
Systems operations support roles
Experience with validated document management systems
Strong working knowledge of Microsoft Office tools
Understanding of system integration (preferred)
Key Skills Required
Strong attention to detail
Ability to manage multiple tasks and priorities
Good communication (written & verbal)
Logical thinking and accuracy in data handling
Strong team collaboration skills
Good keyboard and system operation skills
Ability to work under structured SOP-driven environments
Preferred Skills
Clinical or pharmacovigilance systems background
Basic knowledge of SQL programming
Experience with ticketing/support systems
Familiarity with PV regulatory requirements
Work Environment
Office-based or remote setup
Structured, regulated environment
May involve handling system alerts and time-sensitive issues
Requires multitasking and priority management
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Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Canada |Quebec :
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Japan | Saitama |Tokyo :
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Remote - Europe | Remote | Regulatory Labeling Manager (NA and LATAM Only) | Belgium | Slovakia | Zaragoza | Blue Bell | Thailand | Lousiana | Remote - Middle East | Remote, USA | Ireland | McFarland | Hungary | Remote - South America (Latin Americal) | Lenexa | Springville | Bishop | Green Way | Tulsa | Riga | Castlebar | Medan | Leinster | Bountiful | Xzagreb | Hammond | Texas | French | Manipal | Melbourne | Remote - Africa | Minnesota | Faridabad | Switzerland | Nairobi | Victoria |Republic of Colombia :
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