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    Senior Associate, Pharmacovigilance - Us - Remote

    Worldwide Clinical Trials
    5 years
    Not Disclosed
    Durham North Carolina Remote United States
    10 Jan. 21, 2025
    Job Description
    Job Type: Full Time Remote Education: B.Sc, M.Sc, B.Pharm, M.Pharm and LifeScience Graduates 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 Associate, Pharmacovigilance
    Employer: Worldwide Clinical Trials - USA
    Location: Durham, North Carolina, USA (Homeworking available)
    Salary: Competitive
    Start Date: 7th January 2025
    Closing Date: 6th February 2025

    Company Overview:

    Worldwide Clinical Trials is a global, midsize Contract Research Organization (CRO) focused on pioneering creative approaches to clinical research. We are committed to improving lives by enabling the development of life-changing medical treatments. With a team of over 3,500 professionals worldwide, we prioritize diversity, inclusivity, and collaboration, ensuring that every team member has the opportunity to thrive.

    Job Summary:

    The Senior Associate, Pharmacovigilance will be responsible for the collection, processing, evaluation, and reporting of Serious Adverse Event (SAE) data in compliance with regulatory guidelines, Worldwide Standard Operating Procedures (SOPs), and project-specific instructions. The role will involve independent leadership on moderate to complex studies and programs and will include mentorship and support for junior staff.

    Key Responsibilities:

    • Safety Management: Author the Safety Management Plan for assigned studies.
    • SAE Processing: Independently review, process, and evaluate incoming SAE data for completeness and accuracy. Perform data entry in safety databases and track safety information.
    • Query Management: Generate and follow up on queries for missing or unclear information with sites.
    • Quality Control: Perform Quality Control (QC) of SAEs processed by other Pharmacovigilance Associates.
    • Regulatory Reporting: Generate regulatory reports and submit safety submissions, including Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
    • Client Interaction: Attend internal and client meetings as needed, and present at Investigator Meetings.
    • Mentorship: Provide training and mentorship to new Pharmacovigilance staff.
    • Adherence to Guidelines: Maintain an understanding of safety-related regulations and guidelines and ensure compliance with applicable timelines and safety practices.

    Other Skills and Abilities:

    • Strong understanding of medical terminology, clinical assessment of adverse drug events, international regulations, and reporting requirements.
    • Proficient in computer technology, database management systems, and MS Office applications (Excel, PowerPoint, Word).
    • Excellent communication, organization, and problem-solving skills with the ability to manage multiple priorities and tight deadlines.
    • Ability to work independently, make sound decisions, and contribute effectively to a team environment.
    • Flexibility and adaptability in executing tasks and handling competing priorities.
    • Ability to receive and provide constructive feedback, demonstrating a focus on solutions and problem resolution.

    Requirements:

    • Education: Bachelor’s degree in a science-related field, nursing, or equivalent.
    • Experience: Minimum of 5 years of pharmacovigilance experience (pre-approval clinical trials), or an equivalent combination of relevant education and experience.
    • Skills: Computer literacy with a strong working knowledge of MS Office applications.
    • Language: Fluent in written and verbal English.
    • Travel: Willingness for potential limited domestic and international travel (e.g., Investigator Meetings, project kick-off meetings, or bid defense meetings).
    • Other: Ability to work independently, prioritize tasks effectively, and succeed in a matrix team environment.

    Additional Information:

    • Promotion to the next level is not automatic but based on competency, responsibility, and the ability to work independently.
    • The company reserves the right to amend the job description to reflect organizational changes or emerging business needs.

    Why Join Worldwide?

    Worldwide Clinical Trials is committed to creating a workplace where diverse talent thrives. We foster an environment of collaboration and creativity where every employee feels appreciated and empowered to do their best work. We offer equal employment opportunities regardless of race, gender, nationality, disability, or other protected status.

    Closing Date for Applications: 6th February 2025

    For more information, visit: Worldwide Clinical Trials Careers

     

     

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