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    Sr. Dsa/Dsa

    Sitero - Drug Safety Services
    1-6 years
    Not Disclosed
    Mysore
    12 Feb. 8, 2024
    Job Description
    Job Type: Full Time Education: Any Graduate Skills: Communication Skills, Interpersonal Skill, Technical Skill

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

    • Analyzes, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources
    • Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines
    • Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies
    • Responsible for identifying duplicate/invalid ICSRs
    • Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports
    • Perform data entry for all subject information into EDC databases as required
    • Perform peer review, quality review of cases as and when required
    • Accountable for sending queries for clarity associated with incoming information if required
    • Ensure accurate and consistent coding of all the events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD).
    • Ensure that case narrative comprises correct and appropriate safety information
    • Ensure that all the cases being processed with quality and submitted in a timely manner without any delays according to the service level agreement.
    • Contributes to safety and pharmacovigilance training programs.
    • Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
    • Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
    • Training and mentoring of Pharmacovigilance Associates
    • Assures and exerts activities leading to effective cooperation with clients in literature monitoring.
    • Ensures that the Literature Screening responsibilities and activities are managed in a cost-efficient manner of the highest quality and in compliance with global regulations and company policies and in accordance with any Pharmacovigilance (PV) agreement.
    • To assist with the development of literature search strategy using various methods
    • Perform literature screening activities to identify potential ICSRs and other relevant safety related information pertaining to client products.
    • To maintain a record and track all literature abstracts screened and full literature article reviewed/ordered.
    • To forward any ICSRs to PV Associates for data entry into the global drug safety database
    • Perform peer review QC of abstracts.
    • Accessing EV on daily basis and downloading MLM search and MLM ICSR results (excel spreadsheets)
    • Tracking all the MLM search results, MLM ICSRs list downloads and exported ICSR.
    • Assisting in departmental regulatory inspection preparedness for the company PV system in the EU and actively participating in PV inspections or audits

     

    EDUCATION AND EXPERIENCE REQUIRED:

    • Minimum 1 years of relevant experience in Drug Safety for DSA, minimum 3 years for Sr. DSA role and minimum 1 year of relevant experience in Literature Screening or Literature case processing
    • Degree in Life Science/Pharma or Equivalent

     

    PREFERRED SKILLS:

    • Awareness of Drug Safety database, Scientific coding browser: MedDRA, WHO etc
    • In depth Knowledge and understanding of Drug Safety/Pharmacovigilance regulations with respect to pharmaceutical drugs and other related products
    • Strong organizational, documentation, and interpersonal skills essential to interact with clients, management, peers and cross functional teams effectively.
    • Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
    • Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment).
    • Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
    • Excellent verbal, written and presentation skills.
    • Innovative, collaborative, initiative-taker.

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