Safety Specialist - Smyrna - ACL Digital

    ACL Digital
    ACL Digital Smyrna

    9 hours ago

    $70,000 - $125,000 (USD) per year * Pharmaceutical / Bio-tech
    Description


    • Key responsibilities: Duties include managing US postal follow-up activities, addressing affiliate queries independently, supporting product management documentation, assisting with PV training, and maintaining safety documentation and compliance with drug safety regulations.


    • Qualifications and skills: A bachelor's degree is required, preferably in a health-related field, with 1-2 years of pharmacovigilance experience or an advanced clinical degree as an alternative. The role demands problem-solving skills, proficiency with safety databases and MS Office, and effective communication with international teams.


    • Performance indicators and priorities: Success is measured by compliance with PV follow-up activities and effective communication skills, with a priority to ensure compliance in postal follow-up activities and provide necessary team support in the coming year.

    Accountabilities


    • Supporting routine Pharmacovigilance Operations by managing the fulfillment activities for US postal follow-up letters and independently liaising with the US mailroom as required


    • Independently address queries raised by affiliate/global follow-up team in accordance with internal procedures


    • Product Management team activities: Provide administrative support liaising with marketing team project/program owners to ensure proper documentation is in place, in accordance with SOPs, for programs with Pharmacovigilance impact, and ensure timely updates to the various tracking tools


    • Provide back-up and administrative support as required as US affiliate transitions to the new safety database


    • Support US team in providing Pharmacovigilance Training to vendors/in house personnel as required.


    • Support with proper archival of US Safety documentation/forms


    • Maintain current knowledge of drug safety regulations and procedures


    • Other responsibilities and projects as assigned by manager/company

    Experience (List the type and length of experience)


    • Bachelor's Degree


    • Education in a health-related area highly preferred as well as basic knowledge with the medical terminology.


    • Minimum 1-2 years of Pharmacovigilance Experience preferred or advanced clinical degree (i.e. RN, PharmD) in lieu of direct PV experience


    • Some understanding of Pharmacovigilance and related obligations

    Specific skills (Include specific skills and knowledge necessary to meet the objectives of the position)

    Creative and persistent problem solver. Recognize areas of process improvements related to the function and provide feedback to management

    Takes ownership of meeting high standards

    Ability to prioritize, organize and plan

    Proficiency with safety databases, MS office applications

    Ability to network and effectively communicate with international teams

    Problem solving (Describe the level of "self-starting" thinking required in the for recognizing, analyzing and solving problems)

    Proactive and independent problem solver

    Quality oriented

    High level of creative and innovative thinking

    * This salary range is an estimation made by beBee
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