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    Associate, Regulatory Intelligence And Analytics

    Primevigilance
    0-2 years
    Not Disclosed
    Remote, USA
    10 Nov. 25, 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

    Company Description:
    PrimeVigilance, part of the Ergomed Group, was founded in 2008 by Dr. Miroslav Reljanovic and Dr. Elliot Brown. PrimeVigilance provides comprehensive, cost-effective, and innovative safety services for pharmaceutical, biotechnology, and generic companies. With a network of expert associates across the globe, our founders and leadership team have built an unrivalled reputation in the industry.

    Job Description:
    PrimeVigilance is seeking a Regulatory Intelligence Associate to join our team. In this role, you will be responsible for maintaining the regulatory intelligence database and keeping the team informed about updates in regulatory legislative requirements. You will provide internal guidance on national requirements and ensure compliance with company processes, training, and systems.

    Key Responsibilities:

    • Perform regular screening of updates to regulatory legislative requirements and maintain the regulatory intelligence database.
    • Disseminate relevant changes in regulatory requirements to internal teams in a timely manner.
    • Provide guidance to internal teams on national requirements to ensure compliance with company procedures and regulatory processes.
    • Identify and escalate any risks or potential risks that could jeopardize project deliverables.
    • Track and manage allocated tasks and hours, ensuring that any out-of-scope (OoS) issues are promptly identified and addressed.
    • Provide administrative support for Business Development (BD) activities.
    • Foster professional relationships with both internal and external stakeholders at local and international levels to ensure smooth service delivery.
    • Support audit and inspection preparation and represent the department for assigned projects.
    • Provide feedback on vendor performance to assist in their evaluation.
    • Contribute suggestions for process and procedure improvements within the department.

    Qualifications:

    • Degree in Chemistry, Life Sciences, Nursing, or a related field.
    • Previous work experience is preferable but not required; no prior pharmaceutical or CRO experience necessary.
    • Strong planning and organizational skills.
    • Excellent written and verbal communication skills.
    • Strong interpersonal skills, able to thrive in a fast-paced, deadline-driven environment.
    • High attention to detail and excellent self-motivation.
    • Proficiency in English, both written and spoken.
    • Proficiency in MS Office applications (Word, Excel, PowerPoint).

    Additional Information:
    What We Offer:

    • Diverse tasks including data mining, screenings, analysis, and requirements reviews.
    • The opportunity to develop a broad understanding of Pharmacovigilance (PhV) processes and requirements.
    • The chance to expand your knowledge in related areas, such as clinical trials, marketing authorizations, XEVMPD, and PV Network.
    • A motivating environment where you can contribute to the development of regulatory intelligence processes.

    If you're looking for a role that offers professional growth in the dynamic field of regulatory affairs, PrimeVigilance is the place for you!

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