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    Drug Safety Associate Ii

    Parexel
    2+ years
    Not Disclosed
    Mohali
    10 Sept. 5, 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

    Role: Drug Safety Support

    Key Responsibilities:

    • Safety Procedures Development: Assist in creating and maintaining project-specific safety procedures, workflows, and templates.
    • Database Setup: Support the setup and user acceptance testing of safety databases, including the development of data entry guidelines.
    • Report Triage: Evaluate incoming reports for completeness, legibility, and validity.
    • Documentation and Quality Control: Ensure accurate electronic documentation and quality control of drug safety information.
    • Data Management: Enter case reports into safety databases, manage queries, and code data.
    • Case Narratives: Write detailed case narratives.
    • File Management: Create and maintain project-specific working files, case report files, and central project files.
    • Support: Assist Drug Safety Specialists and Safety Service Project Leaders (SSPL) with additional tasks as needed.
    • Communication: Notify Line Manager, Team Manager, SSPL, or Project Leader of potential project scope changes.
    • Medical Monitoring: Support Medical Directors and Safety Physicians with medical monitoring activities as required.
    • Meetings and Training: Participate in client and investigator meetings, and attend internal, drug safety, and project-specific training sessions.
    • Literature Searches: Perform literature searches relevant to safety.
    • Audit Preparation: Prepare for and participate in audits and inspections, following up as necessary.
    • Delegation: Delegate tasks to Drug Safety Assistants as appropriate.
    • Reporting Procedures: Assist in developing expedited reporting procedures and registering for electronic reporting with relevant authorities.
    • Submission and Tracking: Support the setup and deployment of worldwide reporting, submit safety reports to investigators, track submission cases, and assist with unblinding of SUSARs.
    • Metrics: Support the collection and review of metrics for reporting compliance.

    Skills:

    • Analytical & Problem-Solving: Strong analytical and problem-solving skills.
    • Database Searches: Proficiency in performing database and literature searches.
    • Interpersonal Skills: Excellent interpersonal skills and communication abilities.
    • Organizational Skills: Superior organizational and prioritization skills.
    • Team Collaboration: Ability to work effectively in a team environment with a client-focused approach.
    • Computer Proficiency: Experience with computer applications, including Microsoft Excel and PowerPoint.

    Knowledge and Experience:

    • Healthcare Experience: Related experience in a healthcare environment is advantageous.
    • Pharmaceutical Experience: Minimum of 3 years in the pharmaceutical industry, with at least 2 years in pharmacovigilance, or relevant experience in quality, compliance, or case processing roles.
    • GxP Requirements: Understanding of Good Practice (GxP) requirements.
    • Global Pharmacovigilance: Preferred experience in global pharmacovigilance.
    • Matrix Environment: Ability to function in a global matrix environment.
    • Communication Skills: Excellent communication and writing skills, with a proven ability to manage and resolve issues independently.

    Education:

    • Degree: Bachelor’s Degree in a relevant discipline (e.g., Science, Medical) is required.

    Application Process:

    If you meet the qualifications and are excited about the role, apply to join our team and contribute to drug safety and pharmacovigilance efforts.

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