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Senior Safety Technology Support (Sts) Specialist

3+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Safety Technology Support (STS) Specialist
Company: PrimeVigilance (part of Ergomed PLC)
Location: Remote
Employment Type: Full-time

Company Overview:

PrimeVigilance is a leading pharmacovigilance service provider, part of Ergomed PLC, with a global presence in Europe, North America, and Asia. Established in 2008, PrimeVigilance specializes in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance, providing first-class support to pharmaceutical and biotechnology partners. The company covers all therapy areas, including medical devices. PrimeVigilance invests in its staff by offering excellent training and development platforms and values employee well-being, ensuring a healthy work-life balance.

Job Description:

The Senior Safety Technology Support Specialist will be responsible for managing and optimizing safety databases and related technological applications in the pharmacovigilance (PV) field. This role involves collaborating with the Safety Systems team to gather user requirements, design specifications, and ensure the smooth integration of systems across projects. The Specialist will contribute to the implementation, validation, and optimization of safety systems, as well as train and mentor junior team members.

Key Responsibilities:

  • Lead Safety Systems Technology Support for safety database and other PV systems.
  • Gather, analyze, and document user requirements for safety system enhancements.
  • Collaborate with the Safety Systems team to translate requirements into system designs and reports.
  • Participate in the design, testing, and delivery of training for safety systems.
  • System configuration, administration, and maintenance of safety databases (e.g., Argus) for project-specific needs.
  • Support internal and external audits, providing system demonstrations and data migrations.
  • Develop and maintain SOPs, templates, and forms related to Safety Systems.
  • Quality checks of listings, reports, and queries from the safety database for regulatory and client use.
  • Mentor and train junior Safety Technology Support Specialists.
  • Assist with the development and delivery of training materials for users and functional area trainers.
  • Advise PV users on the use of alternate client databases and other PV technologies.
  • Represent the Safety Technology Support team in meetings with clients and project teams.

Qualifications:

  • Life science graduate, pharmacy, nursing, or related healthcare qualifications.
  • Minimum 3 years of experience working with safety applications and systems (preferably Argus).
  • Experience as a safety database application administrator.
  • Strong communication skills (both written and verbal).
  • Organizational skills, attention to detail, and ability to multitask.
  • Delegation, planning, and time management skills.
  • Technical skills related to safety systems and databases.
  • Ability to work collaboratively in a team environment.
  • Advanced proficiency in MS Office (Word, Excel, PowerPoint, etc.).
  • Fluent in English, both spoken and written.

Why PrimeVigilance?

PrimeVigilance values diversity, equity, and inclusion, creating an equal opportunities workplace that celebrates all cultural backgrounds, genders, and ages. The company emphasizes personal and professional growth through internal training and career development opportunities. Employees benefit from a supportive, collaborative environment with the chance to work with global teams, making a meaningful impact on patient lives.

Core Values:

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

If you resonate with these values and have the expertise in safety system management, PrimeVigilance could be the ideal company for your next career step.


This position provides the opportunity to be a part of a growing and dynamic team, offering leadership, mentorship, and a chance to work with global experts in pharmacovigilance and safety systems.