Safety Systems Specialist

Company Description:

PrimeVigilance (part of Ergomed Group)

• Established: 2008
• Type: Specialised mid-size pharmacovigilance service provider
• Global Presence: Europe, North America, Asia

Services Provided:

1. Medical Information
2. Pharmacovigilance
3. Regulatory Affairs
4. Quality Assurance

Key Highlights:

• Global Leader: Known for first-class support to pharmaceutical and biotechnology partners
• Therapy Areas: All-inclusive, including medical devices
• Employee Focus: Emphasis on training, development, well-being, and mental health
• Work-Life Balance: Acknowledged as critical for employee satisfaction and high-quality client service

Mission Statement: Join us in making a positive impact on patients' lives.

Job Description:

Position: Safety Database Specialist

Team: Safety Information System Team

Responsibilities:

1. Database Activities:

   • Data migrations requiring strong SQL developer skills
   • Providing technical expertise on pharmacovigilance systems (Argus Safety database)
   • Planning and validation of database-related activities
   • Support and maintain the adverse event reporting system
   • Ensure compliance with regulatory requirements, policies, and standards

2. Subject Matter Expertise:

   • Pharmacovigilance systems (Argus 8.x Oracle Cloud) and associated application integrations (e.g., OAS, Axway)
   • Lead client data transfers (data imports and exports)
   • Develop, validate, and implement standard and custom reports
   • Query database to support inspections as required

3. Efficiency and Quality:

   • Identify database requirements to maximize efficiency and quality
   • Investigate, develop, and implement solutions
   • Present solutions to management proactively

4. Project Management:

   • Configuration/validation of the pharmacovigilance master tenant enterprise
   • Lead project kick-off for client enterprise creation, validation, and configuration
   • Gather functional and technical requirements
   • Provide configuration solutions to support client case processing and reporting

5. System Upgrades and Issues:

   • Lead safety database and associated systems upgrades/patches
   • Project planning, testing, and implementation
   • Manage and escalate system issues with pharmacovigilance software vendors

6. Documentation and Training:

   • Author pharmacovigilance system work instructions, SOPs, and associated forms
   • Maintain professional and technical knowledge through continuing education
   • Develop staff knowledge through individual mentoring, classroom training, and user workshops

7. Compliance and Additional Tasks:

   • Ensure compliance with relevant company policies and procedures
   • Accept project assignments as delegated by senior staff

Qualifications:

• Bachelor's degree in Information Technology or related experience
• Knowledge and experience with pharmacovigilance systems in a pharmaceutical company, biotech, or CRO (on-premise or cloud-based)
• Experience supporting Oracle Argus Safety system and application integrations (e.g., OAS, Axway)
• Understanding of pharmacovigilance processes and ability to implement technical solutions
• Proficient SQL and/or PS/SQL skills
• Excellent people and project management skills
• Experience with system validation and compliance with global regulations
• Strong analytical/problem-solving skills and ability to multi-task
• Excellent oral and written communication skills
• Ability to work within a global Safety Information Systems team

Additional Information:

Why PrimeVigilance?

Core Values:

1. Quality
2. Integrity & Trust
3. Drive & Passion
4. Agility & Responsiveness
5. Belonging
6. Collaborative Partnerships

What We Offer:

• Training and career development opportunities
• Emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work globally with English as the company language
• Equal opportunities workplace promoting diversity, equity, and inclusion

Mission Statement: We believe our people are our greatest strength, leading to our success in improving lives. We look forward to welcoming your application.