Senior Safety Technology Support (STS) Specialist

Company Description

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. 

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives. 

Job Description

Responsible for leading Safety Systems Technology Support related to the safety database and other technological applications and safety systems utilised by PV. Gathers, analyses and documents user requirements for various business initiatives; liaises with the Safety Systems team to ensure requirements are appropriately translated into design specifications for systems and reports. Supports safety system optimization activities. Participates in the design, development and delivery of user trainings for all safety systems. Supports the implementation and adoption of new safety systems/upgrades across all projects.

• Participates in audits and performs system demonstrations when required
• Works with the Safety Systems team to define system requirements for the business
• Participates in testing development features, business enhancements and validation activities for all safety systems
• Participates in the development and maintenance of of SOPs/OGs/templates/forms related to Safety Systems
•Comprehensive understanding of IT SOPs and OGs that impact the business processes associated with Safety Systems
• Analyses and assists with programs for internal and external regulatory or customer report needs from Safety Systems
• Supports the implementation of efficiencies related to PV processes in all safety systems
• Configures, administers and maintains the safety database on a per project basis to ensure client specific requirements are met
• Participates in the development, validation, testing and maintenance of safety reporting tools (e.g. Business Objects)
• Creates and maintains Argus project information, Argus product/Licenses, Argus User Access and Report Request forms
• Assists with the development and delivery of safety systems and safety database-related training materials for End Users and functional area trainers
• Supports the implementation and adoption of new safety systems/upgrades across all projects.
• Trains and mentors junior Safety Technology Support Specialists
• Performs other tasks related to the support of Safety Systems as necessary
• Advises and assists PV Users with the use of alternate client databases
• Assists with other PV technology and systems initiatives as needed
• Participates in the planning, writing and execution of Safety System Data Migrations and custom reports
• Generates and performs quality checks of listings, reports and queries from the safety database for internal, client or regulatory use
• Assists in representing the Safety Technology Support team at project team and client meetings and performs system demonstrations when required
• Maintain a high level of expertise regarding PV Safety Systems and applications through participating in internal meetings

Qualifications

- Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance

- Minimum three (3) year experience with safety applications and systems
Safety database application administrator experience required (preferably Argus)· Excellent communication (written and verbal) skills

· Organization skills, including attention to details and multitasking
· Delegation skills
· Planning and time management
· Technical skills
· Team workingEnglish - advanced (spoken, written)Advanced literacy (MS Office)

Additional Information

Why PrimeVigilance? 

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

We offer: 

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth 
• Friendly, supportive working environment 
• Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality 
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging 
• Collaborative Partnerships

We look forward to welcoming your application.