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    Drug Safety Associate Ii

    Parexel
    2+ years
    Preffered by Company
    Mohali
    10 Sept. 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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 Parexel: Where Values Drive Achievements

    At Parexel, our shared goal is to enhance global health. Whether in clinical trials, regulatory affairs, consulting, or market access, our commitment is grounded in a deep conviction for our work. Every role at Parexel contributes to developing therapies that ultimately benefit patients. We approach our work with empathy and a personal commitment to making a difference.

    Role: Drug Safety Support

    Key Responsibilities:

    • Safety Procedures: Assist in developing project-specific safety procedures, workflows, and templates.
    • Database Setup: Support the setup of safety databases, create data entry guidelines, and conduct user acceptance testing.
    • Report Management: Triage incoming safety reports for completeness and validity. Perform data entry, coding, and quality control of case reports.
    • Query Management: Request follow-ups, manage queries, and write case narratives.
    • Documentation: Maintain project-specific files, central files, and assist in the development of expedited reporting procedures.
    • Regulatory Compliance: Assist with registration for electronic reporting, and handle worldwide reporting requirements for regulatory authorities and investigators.
    • Client and Investigator Interaction: Participate in client and investigator meetings, and support Medical Directors/Safety Physicians in medical monitoring activities.
    • Training and Audits: Attend relevant training sessions and support preparation for audits and inspections.
    • Metric Collection: Support the collection and review of metrics to measure reporting compliance.

    Skills Required:

    • Analytical Skills: Strong problem-solving abilities and experience with database/literature searches.
    • Communication: Excellent verbal and written communication skills.
    • Organizational Skills: Superior organizational and prioritization abilities.
    • Team Collaboration: Ability to work effectively in a team environment with a client-focused approach.
    • Technical Proficiency: Experience with Microsoft Excel and PowerPoint.

    Knowledge and Experience:

    • Relevant Experience: Minimum of 3 years in the pharmaceutical industry, with 2 years in pharmacovigilance preferred. Experience in quality, compliance, or case processing roles is highly desirable.
    • GxP Understanding: Knowledge of Good Clinical Practice (GxP) requirements.
    • Global Experience: Global pharmacovigilance experience is preferred.
    • Matrix Environment: Ability to function effectively in a global matrix environment.

    Education:

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

    At Parexel, your role not only advances your career but also contributes to significant health improvements worldwide. If this role resonates with you, apply to join our dedicated team.

    Equal Opportunity Employer

    Parexel is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We do not discriminate based on race, religion, sex, color, age, national origin, disability, or any other protected characteristic.

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