Job Title
Pharmacovigilance (PV) Systems Specialist / Safety Systems Associate
Role Overview
The PV Systems Specialist is responsible for supporting the implementation, configuration, migration, and maintenance of pharmacovigilance (PV) safety systems. The role involves providing technical and operational support for internal and external clients while ensuring high-quality, compliant, and cost-effective service delivery.
The position also supports safety database operations, reporting, data migration, user training, issue resolution, and system validation activities in compliance with applicable pharmacovigilance regulations and company SOPs.
Key Responsibilities
1. Safety System Support & Configuration
Assist in implementation, configuration, and migration of safety systems
Perform project-specific configurations in PV safety systems
Maintain and document system configurations and updates
Support system integration activities
2. Reporting & Data Management
Develop and generate standard and ad hoc safety reports
Conduct routine and ad hoc data extractions, including:
PSURs (Periodic Safety Update Reports)
DSURs (Development Safety Update Reports)
6-monthly listings
Ensure data accuracy and completeness
3. Data Migration & Validation
Participate in all data migration activities and related documentation
Perform User Acceptance Testing (UAT)
Complete validation and testing documentation
4. End User & Sponsor Support
Support and educate end users and sponsors on safety systems
Respond to user mailbox queries
Monitor system failure mailboxes and resolve issues promptly
Escalate unresolved technical issues where necessary
5. Ticket & Issue Management
Support ticket management and issue tracking processes
Investigate and resolve operational/system-related issues
Ensure timely follow-up and closure of support tickets
6. Training & Change Management
Support system change management activities
Train team members on technical and functional system aspects
Assist with process and system training initiatives
7. Compliance & Quality
Ensure compliance with:
Pharmacovigilance regulations
Company SOPs
Health & Safety policies
Maintain high-quality standards in all assigned work
Keep updated with current PV regulations and industry practices
8. Additional Responsibilities
Perform any additional duties assigned by management
Support operational and project-based activities as required
Required Qualifications
Education
Bachelor’s degree in:
Life Sciences
IT / Computer Science
Related field
Equivalent relevant experience may be considered in place of formal education
Technical Experience
Experience in systems operations support
Minimum 2 years of experience with drug safety systems such as:
Argus
ARISg
Veeva
Equivalent PV systems
Experience with validated document management systems
Good working knowledge of:
Microsoft Office tools
Windows-based applications
Basic understanding of system integration
Required Skills & Competencies
Core Skills
Strong attention to detail
Ability to prioritize and manage multiple tasks
Good analytical and logical thinking skills
Strong written and verbal communication skills
Good keyboard and documentation skills
Team & Collaboration
Team-oriented mindset
Ability to provide peer support and collaborate effectively
Customer-focused approach
Operational Skills
Ability to handle technical and operational queries
Ability to proofread and manage numerical data accurately
Comfortable using standard office equipment
Preferred Qualifications
Clinical background with experience using clinical systems
Good understanding of SQL programming language
Experience with ticketing/support applications
Additional exposure to pharmacovigilance operations
Work Environment
Office-based or remote working environment
Collaborative, compliance-driven setting
Involves cross-functional coordination and system support activities
Compliance & Safety Requirements
Employees are expected to comply with:
Health and Safety at Work Act 1974
COSHH Regulations 1989
EC Directives 1992/3
Company Health & Safety policies and procedures
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