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Senior Safety Technology Support (Sts) Specialist

3+ years
Not Disclosed
10 Oct. 17, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Company Description

We are PrimeVigilance, part of Ergomed PLC, a specialized mid-sized pharmacovigilance service provider established in 2008. We take pride in our consistent global organic growth, with a dedicated team across Europe, North America, and Asia providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance delivers top-notch support to pharmaceutical and biotechnology partners, maintaining long-lasting relationships and establishing ourselves as a global leader in the field. We cover all therapy areas, including medical devices.

We are committed to investing in our employees through excellent training and development programs. We value employee experience, well-being, and mental health, recognizing that a healthy work-life balance is crucial for satisfaction and high-quality client service.

Join us on this exciting journey to make a positive impact on patients' lives!

Job Description

We are looking for a Safety Systems Technology Support Lead to oversee our safety database and other technological applications used in pharmacovigilance (PV). This role involves gathering, analyzing, and documenting user requirements for various business initiatives, working closely with the Safety Systems team to ensure accurate translation into design specifications, and supporting safety system optimization activities. Key responsibilities include:

  • Leading audits and conducting system demonstrations as required.
  • Collaborating with the Safety Systems team to define system requirements.
  • Participating in testing development features and validation activities for all safety systems.
  • Developing and maintaining SOPs, OGs, templates, and forms related to Safety Systems.
  • Analyzing and assisting with internal and external regulatory report needs.
  • Configuring, administering, and maintaining safety databases to meet client-specific requirements.
  • Participating in the development and validation of safety reporting tools (e.g., Business Objects).
  • Creating and maintaining Argus project information, user access, and report request forms.
  • Training and mentoring junior Safety Technology Support Specialists.
  • Assisting with PV technology initiatives and safety system data migrations.
  • Generating quality checks for listings, reports, and queries from the safety database.

Qualifications

  • Life science graduate (pharmacy, nursing, or other healthcare-related qualification).
  • Minimum of three (3) years of experience with safety applications and systems.
  • Experience as a safety database application administrator (preferably Argus).
  • Excellent written and verbal communication skills.
  • Strong organizational skills, attention to detail, and multitasking abilities.
  • Effective delegation, planning, and time management skills.
  • Proficient technical skills and ability to work in a team.
  • Advanced English proficiency (spoken and written).
  • Strong literacy in MS Office applications.

Additional Information

Why PrimeVigilance?

We prioritize diversity, equity, and inclusion by fostering an equal-opportunity workplace that encourages contributions from all cultural backgrounds, genders, and ages.

Our success relies on a human-first approach, as our people are our greatest asset, leading to ongoing success in improving lives.

We offer:

  • Internal training and career development opportunities.
  • Strong emphasis on personal and professional growth.
  • A friendly and supportive working environment.
  • Opportunities to collaborate with colleagues worldwide, with English as the primary language.

Our core values guide our operations, and if they resonate with you, PrimeVigilance could be the perfect fit!

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

We look forward to welcoming your application!