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    Drug Safety Associate Ii, Pharmacovigilance - Us - Remote

    Worldwide Clinical Trials
    2-3 years
    Not Disclosed
    Durham North Carolina Remote, USA 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: Drug Safety Associate II, Pharmacovigilance
    Employer: Worldwide Clinical Trials - USA
    Location: Durham, North Carolina, United States; Homeworking
    Start Date: 16th January 2025
    Closing Date: 15th February 2025

    Company Overview:

    Worldwide Clinical Trials is a global, midsize Clinical Research Organization (CRO) that strives to push boundaries and innovate in the pursuit of cures for the world’s most persistent diseases. With a team of over 3,500 experts, Worldwide Clinical Trials fosters an inclusive and collaborative environment that prioritizes creativity, quality, and excellence.

    Job Summary:

    The Drug Safety Associate II, Pharmacovigilance will be responsible for the collection, processing, and evaluation of information on Serious Adverse Events (SAEs) reported to the company. The role includes preparing summary narratives, assigning regulatory reporting statuses, and accurately entering data into the Drug Safety Database. The associate will assist the Drug Safety Manager/Officer in preparing periodic safety reports and provide routine data extraction and reporting services.

    Key Responsibilities:

    • Case Evaluation: Evaluate case information, determine the regulatory reporting status, and accurately enter case details into the safety database.
    • Data Retrieval and Reporting: Retrieve and report data from the global safety database. Perform ad hoc data extraction as requested by internal and external stakeholders.
    • Regulatory Reports: Support the generation of safety update reports (ASR, Periodic Line Listings) and other regulatory reports.
    • Cross-Functional Collaboration: Work closely with other functions (e.g., ClinOps, Data Management) for database reconciliation and case handling.
    • Study-Specific Safety Monitoring Plans: Support the preparation of study-specific safety monitoring plans to understand how SAE cases are managed in specific studies.
    • Safety Signal Generation: Contribute to safety signal generation and evaluation through database searches and data extraction.
    • Regulatory Knowledge: Keep updated on the laws, guidelines, and regulations regarding drug safety.
    • Other Duties: Perform additional tasks as assigned by management.

    Other Skills and Abilities:

    • Strong understanding of medical and scientific terminology and principles of clinical assessment of adverse drug events.
    • Knowledge of international regulations and reporting requirements related to drug safety.
    • Proficient in computer technology, particularly in managing relational databases and data extraction.
    • Good oral and written communication skills.
    • Strong organizational and time management skills.
    • Fluency in English (both written and verbal).

    Minimum Required Education and Experience:

    • Education: Bachelor’s degree in a science-related field, nursing, or an equivalent qualification.
    • Experience: Proven competency in drug safety, pharmacovigilance, or a related field.
    • Promotion Criteria: Promotion to the next level is based on demonstrated competency, responsibility, and the ability to work independently, not just years of experience.

    About Worldwide Clinical Trials:

    Worldwide Clinical Trials is dedicated to improving lives through pioneering and innovative approaches to clinical trials. The company is committed to cultivating a diverse and inclusive environment where all employees feel valued and can thrive. Worldwide Clinical Trials prioritizes collaboration, creativity, and excellence in its work to bring forward groundbreaking medical treatments.

    Diversity & Inclusion:

    Worldwide Clinical Trials is an equal opportunity employer, welcoming professionals from all backgrounds and experiences. The company fosters a diverse and inclusive work culture that encourages creativity, innovation, and success by ensuring that all employees have the opportunity to contribute to the mission of improving patient outcomes globally.

    Additional Information:

    • Visa Sponsorship: This role does not offer visa sponsorship.
    • Application Deadline: 15th February 2025

    For more information, visit Worldwide Clinical Trials Careers or connect on LinkedIn.

     

     

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