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    Drug Safety Specialist

    Parexel
    4-5 years
    Not Disclosed
    India Mohali
    10 Feb. 10, 2025
    Job Description
    Job Type: 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

    Job Title: Drug Safety Specialist
    Location: India-Mohali
    Job ID: R0000030170
    Category: Medical Sciences

    Job Purpose

    The Drug Safety Specialist will provide technical and process-related support to drug safety management for clinical trials and post-marketed products. This role ensures compliance with relevant regulations and Standard Operating Procedures (SOPs). The primary responsibilities include processing Individual Case Safety Reports (ICSRs), conducting literature searches and reviews, signal detection, tracking regulatory information, performing regulatory submissions, and supporting the preparation of aggregate and other study reports.

    Key Responsibilities

    General Responsibilities

    • Maintain a thorough knowledge of the adverse event safety profile of assigned drugs, labeling documents, and relevant client guidelines/SOPs.
    • Ensure compliance with global regulatory reporting obligations and manage work to meet internal and regulatory timelines.
    • Assist in the development of project-specific safety procedures, workflows, and templates.
    • Attend or conduct internal drug safety and project-specific training sessions.
    • Participate in audits and inspections and follow up on actions.
    • Strive to maintain performance metrics within established limits.
    • Delegate tasks to Drug Safety Assistants as required.
    • Collaborate with relevant client functions to ensure high-quality work delivery.
    • Identify areas of concern and raise issues with senior management.
    • Mentor new recruits, as necessary.
    • Archive source documents and relevant emails as required.
    • Respond to clients/customers in a timely manner.

    Case Processing

    • Monitor incoming reports from various sources, including mailboxes, Eudravigilance, literature searches, etc.
    • Triage incoming reports for completeness, legibility, and validity, including literature abstracts and citations.
    • Perform checks on medical cohesiveness and consistency.
    • Analyze data provided by affiliates and compare with client application data.
    • Create cases on the safety database and perform accurate data entry.
    • Perform causality assessment, seriousness criteria, and MedDRA coding.
    • Request follow-ups and manage queries as necessary.
    • Prepare cohesive case narratives based on the reported information.
    • Perform quality checks and validation.
    • Perform literature searches as per defined strategy and enter valid cases into the database.
    • Coordinate case reconciliation activities with Data Management personnel.
    • Generate line listings and tabulations for safety reports.
    • Investigate late case submissions and ensure compliance with reporting requirements.

    Drug Safety Reporting

    • Ensure the quality control of case reports, line listings, and tabulations.
    • Develop and maintain expedited reporting procedures.
    • Maintain local drug safety reporting requirements and ensure timely submission to relevant authorities.
    • Perform setup and deployment of global reporting to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy).
    • Submit safety reports to investigators and track filing of submission cases.
    • Perform unblinding of SUSARs, as required.
    • Track and report metrics for reporting compliance.
    • Collaborate with the Global PV Information Office for the organization of global pharmacovigilance requirements.

    Literature Search and Review

    • Develop and maintain search strategies to identify scientific and medical literature articles.
    • Perform periodic reviews of the database and update search strategies accordingly.
    • Interact with internal/external contacts to resolve issues related to literature searches.
    • Review records, enter valid cases into the client database, and ensure quality control.

    Skills Required

    • Strong knowledge of drug safety and the drug development process.
    • Proficient in interpreting and applying global safety regulations.
    • Experience in safety data analysis and evaluation.
    • Excellent presentation and communication skills.
    • Strong analytical and problem-solving abilities.
    • Proficient in regulatory submission processes.
    • Expertise in database/literature searches.
    • Strong organizational and prioritization skills.
    • Ability to work collaboratively in a team environment.
    • Client-focused approach with the ability to evaluate data independently.
    • Proficient in MS Office suite (Word/Excel/PowerPoint) and web-based applications.

    Knowledge and Experience

    • At least 4 years of experience in drug safety/pharmacovigilance.
    • Strong knowledge of medical terminology.

    Education

    • Degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics).
    • A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing with hospital-based patient exposure is advantageous.

    This position is an exciting opportunity for individuals who are passionate about drug safety and pharmacovigilance. You will be part of a dynamic team working to ensure the safety and compliance of drugs in clinical and post-marketing phases.

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