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    Drug Safety Associate

    Sitero
    0-2 years
    Not Disclosed
    Remote
    10 Oct. 30, 2024
    Job Description
    Job Type: Full Time 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

    Company Overview

    Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. We bring extensive experience across diverse therapeutic areas, focusing on innovative, technology-enabled solutions that allow our clients to concentrate on their core strengths. Our experienced team provides high-touch services and technology for early phase studies through Phase III clinical trials, ensuring the safety of all stakeholders in the clinical research community, with an emphasis on ethics, compliance, and innovation.

    Job Title: Drug Safety Associate (DSA)

    Location: Mysore
    Function: Drug Safety

    Job Description

    The Drug Safety Associate (DSA) is a safety professional responsible for assessing the safety of pharmaceutical drugs during clinical trials and in the market. Using standard guidelines, the DSA determines whether medications cause adverse reactions in patients and reports findings to regulatory bodies and health authorities.

    As part of a dedicated team of safety professionals at Sitero, the DSA will collaborate closely with safety teams in Contract Research Organizations (CROs) and partners. This role requires maintaining medical knowledge, strong familiarity with drug safety and pharmacovigilance regulations, and expertise in safety surveillance and risk management.

    Essential Duties and Responsibilities

    • Analyze, review, and interpret safety data from non-clinical and clinical sources, literature, and other relevant information.
    • Perform end-to-end case processing of Individual Case Safety Reports (ICSRs) to meet regulatory timelines.
    • Conduct initial evaluations of spontaneously reported adverse events, including those from post-marketing surveillance studies.
    • Identify duplicate/invalid ICSRs and process cases from various sources, including clinical trials and literature.
    • Enter subject information into EDC databases as required.
    • Conduct peer and quality reviews of cases and EDC data as needed.
    • Send queries for clarity associated with incoming information when required.
    • Ensure accurate coding of all events, drugs, procedures, indications, and laboratory tests using appropriate dictionaries (e.g., MedDRA, WHO-DD).
    • Write case narratives that accurately reflect safety information.
    • Ensure timely processing of cases according to service level agreements.
    • Contribute to safety and pharmacovigilance training programs.
    • Collaborate with Regulatory Affairs to report pharmacovigilance and drug safety information to regulatory agencies and the prescriber community.
    • Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
    • Train and mentor Pharmacovigilance Associates.

    Education and Experience Required

    • Minimum 1+ year of experience in drug safety or the clinical research domain.
    • Degree in Life Science/Pharma or equivalent.

    Preferred Skills

    • 1+ year of experience in drug safety or clinical research.
    • Familiarity with safety databases and scientific coding browsers (e.g., MedDRA, WHO).
    • In-depth knowledge of drug safety and pharmacovigilance regulations for pharmaceutical products.
    • Strong organizational, documentation, and interpersonal skills for effective interaction with clients, management, peers, and cross-functional teams.
    • 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 (literature, solicited, and post-marketing environments).
    • Ability to build relationships, collaborate, and influence across disciplines within Sitero and with external stakeholders.
    • Excellent verbal, written, and presentation skills.
    • Innovative, collaborative, and proactive.

    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, one hour lunch, Monday – Friday.
    • Willingness to work shifts as needed.

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