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    Drug Safety Associate I

    Parexel
    Freshers years
    Not Disclosed
    Mohali
    10 Aug. 13, 2024
    Job Description
    Job Type: Full Time Remote 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

    Join Us at Parexel: Where Your Values and Passion Make a Difference

    At Parexel, we share a common goal: improving global health. Whether it's through clinical trials, regulatory consulting, or market access, every solution we provide is fueled by a deep conviction in our mission. Our commitment to making a difference is personal, driven by empathy, and aimed at benefiting patients around the world.

    As a Drug Safety Associate, you'll play a critical role in supporting drug safety management and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Your work will contribute to the development of therapies that have the potential to change lives.

    Key Responsibilities

    Drug Safety Support:

    • Assist in developing project-specific safety procedures, workflows, and templates.
    • Support the setup of safety databases, data entry guidelines, and user acceptance testing.
    • Triage incoming reports for completeness, legibility, and validity.
    • Document and quality control drug safety information electronically.
    • Enter case reports into the safety database/tracking system.
    • Manage follow-up requests and queries.
    • Code data in the safety database and write case narratives.
    • Maintain project-specific working files, case report files, and project central files.
    • Support Drug Safety Specialists and Safety Service Project Leaders (SSPL) as needed.
    • Inform relevant managers of potential scope changes in projects.
    • Assist Medical Directors/Safety Physicians with medical monitoring activities.
    • Participate in client and investigator meetings as required.
    • Attend internal and project-specific drug safety training sessions.
    • Perform literature searches and contribute to audits and inspections.
    • Delegate work to Drug Safety Assistants as appropriate.
    • Help develop Expedited Reporting Procedures.
    • Support registration with relevant authorities for electronic reporting on behalf of sponsors.
    • Assist with global reporting to regulatory authorities, CECs, local ECs, and investigator sites.
    • Submit safety reports via the International Safety Information System (ISIS).
    • Track and file submission cases as needed.
    • Assist with the unblinding of SUSARs and support compliance metrics collection.

    Skills Required

    • Strong analytical and problem-solving abilities.
    • Ability to perform database and literature searches.
    • Excellent interpersonal and communication skills.
    • Strong organizational and prioritization skills.
    • Ability to work effectively in a team environment.
    • Client-focused approach to work.
    • Proficiency with computer applications.

    Knowledge and Experience

    • Fresher or related experience in a healthcare environment is an advantage.

    Education

    • Master’s degree in Pharmacy, Doctor of Pharmacy, Master’s degree in Clinical Research/Pharmacovigilance, or Bachelor of Dental Surgery.

    At Parexel, we value your passion and dedication. Together, we can make a lasting impact on global health.

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