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    Senior Safety Technology Support (Sts) Specialist

    Primevigilance
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 19, 2024
    Job Description
    Job Type: Full Time 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

    Job Title: Safety Systems Technology Support Specialist

    Company Description: PrimeVigilance, part of Ergomed PLC, is a leading pharmacovigilance service provider, specializing in delivering high-quality solutions for the pharmaceutical and biotechnology industries. Established in 2008, we have achieved steady global growth with staff across Europe, North America, and Asia. Our services cover Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We are dedicated to maintaining long-term relationships with our clients, which range from small biotech companies to large multinational pharmaceutical organizations.

    At PrimeVigilance, we invest in our employees’ growth and well-being, offering excellent training programs and a supportive work environment. We recognize the importance of work-life balance and aim to create a place where our staff can thrive, ensuring the best possible service for our clients.

    Join us as we continue our mission to make a positive impact on patient lives.

    Job Description: We are seeking a Safety Systems Technology Support Specialist to lead the support and optimization of safety systems used in pharmacovigilance. This role involves managing safety databases, system enhancements, and supporting the implementation of new safety technologies.

    Key Responsibilities:

    • Lead Safety Systems Technology Support, including managing safety databases and other PV-related technological applications.
    • Gather, analyze, and document user requirements for business initiatives, collaborating with the Safety Systems team to ensure proper design specifications are met.
    • Assist in the optimization of safety systems and processes.
    • Participate in testing and validation of system features and business enhancements.
    • Develop, maintain, and revise SOPs, guidelines, templates, and forms related to Safety Systems.
    • Assist with internal and external regulatory reports generated from Safety Systems.
    • Configure, administer, and maintain safety databases to meet client-specific requirements.
    • Develop and maintain safety reporting tools, such as Business Objects.
    • Support the development and delivery of safety systems and safety database-related training.
    • Mentor and train junior Safety Technology Support Specialists.
    • Participate in data migrations, custom report writing, and execution related to safety systems.
    • Generate quality checks of listings, reports, and queries from safety databases for internal, client, or regulatory use.
    • Assist with the implementation and adoption of new safety systems or upgrades across all projects.
    • Represent the Safety Technology Support team in project meetings and client interactions, including system demonstrations.

    Qualifications:

    • A life sciences graduate (Pharmacy, Nursing, or other healthcare-related qualification) with experience in pharmacovigilance.
    • Minimum of three years of experience with safety applications and systems, preferably as a Safety Database Application Administrator (e.g., Argus).
    • Strong communication skills (both written and verbal).
    • Excellent organization, multitasking, and delegation skills.
    • Proficiency in planning and time management.
    • Strong technical skills and a solid understanding of MS Office.
    • Ability to work effectively in a team environment.
    • Advanced English proficiency (spoken and written).

    Why PrimeVigilance? At PrimeVigilance, we prioritize diversity, equity, and inclusion, creating a workplace where people from all cultural backgrounds and walks of life can contribute and grow. We believe in a human-first approach to success, and our people are the key to our continued growth.

    We Offer:

    • Ongoing internal training and career development opportunities.
    • A focus on both personal and professional growth.
    • A friendly, supportive, and global work environment.
    • An opportunity to collaborate with colleagues from across the world, with English as the company language.

    If our core values resonate with you, PrimeVigilance could be the perfect place for you to advance your career.

    Core Values:

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

    We look forward to receiving your application.

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