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    Drug Safety/Sr. Drug Safety Associate

    Sitero - Drug Safety Services
    2+ years
    Not Disclosed
    Mysore
    10 May 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Company Name: Sitero

    Job Title: Senior Drug Safety Associate

    Location: Mysore

    Function: Drug Safety

    Description: Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We provide innovative, technology-enabled solutions across various therapeutic areas to ensure the safety of all stakeholders in clinical research. We are currently seeking a Senior Drug Safety Associate to join our team in Mysore. The Senior Drug Safety Associate will play a crucial role in assessing the safety of pharmaceutical drugs undergoing clinical trials or in the market. They will analyze safety data, perform case processing, and ensure compliance with regulatory requirements.

    Essential Duties and Responsibilities:

    • Analyze, review, and interpret safety data from various sources.
    • Perform end-to-end case processing of individual case safety reports.
    • Conduct initial evaluation of adverse events reported in clinical trials and post-marketing surveillance studies.
    • Identify duplicate or invalid Individual Case Safety Reports (ICSRs).
    • Enter subject information into Electronic Data Capture (EDC) databases.
    • Perform peer review and quality review of cases and EDC data.
    • Ensure accurate and consistent coding of events, drugs, procedures, and laboratory tests.
    • Contribute to safety and pharmacovigilance training programs.
    • Collaborate with Regulatory Affairs for appropriate reporting to regulatory agencies.
    • Serve as a subject matter expert for vendors providing drug safety services.
    • Train and mentor Pharmacovigilance associates.

    Education and Experience Required:

    • Minimum 3 years of relevant experience in drug safety or clinical research.
    • Degree in Life Science/Pharma or equivalent.

    Preferred Skills:

    • 2+ years of relevant experience in drug safety or clinical research.
    • Awareness of safety databases and scientific coding browsers (e.g., MedDRA, WHO).
    • In-depth knowledge of Drug Safety/Pharmacovigilance regulations.
    • Strong organizational, documentation, and interpersonal skills.
    • Good working knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines.
    • Experience with safety data collection and interpretation from clinical trials and other sources.
    • Ability to build relationships, collaborate, and influence across disciplines.
    • Excellent verbal, written, and presentation skills.
    • Innovative, collaborative, and proactive attitude.

    Compensation & Benefits: Sitero offers a competitive compensation package, including a competitive salary, variable pay, paid time off, and healthcare and retirement benefits.

    Employment Type: Full Time, Permanent

    Commitments:

    • Standard Hours: 40 hours per week, Monday to Friday, with additional hours as needed.
    • Willingness to work in shifts as required.

    Disclaimer: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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