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    Pharmacovigilance Services Analyst

    Accenture
    3-5 years
    Not Disclosed
    Bangalore
    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

    Job Description: Pharmacovigilance Services Analyst

    Skill Required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance

    Designation: Pharmacovigilance Services Analyst

    Qualifications: Bachelor’s or Master’s in Pharmacy

    Years of Experience: 3 to 5 years

    Language Proficiency: Elementary Japanese (N3 JLPT certified)

    About Accenture:

    Accenture is a leading global professional services company with expertise in digital, cloud, and security solutions. With unmatched experience and specialized skills across more than 40 industries, we provide Strategy and Consulting, Technology and Operations services, and Accenture Song. Our 699,000 employees deliver innovative technology and human ingenuity, serving clients in over 120 countries. We drive change to create value and shared success for clients, people, shareholders, partners, and communities. Learn more at www.accenture.com.

    Role Overview:

    As a Pharmacovigilance Services Analyst, you will be an integral part of our Life Sciences R&D vertical. Your role involves managing and analyzing pharmacovigilance data, ensuring compliance with global regulatory requirements, and supporting the safety surveillance of drug products. You will handle case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for Individual Case Safety Reports (ICSRs) in the safety database.

    Key Responsibilities:

    • Case Management:

      • Oversee the management of the Affiliate Mailbox, reconcile reports according to process, and perform follow-ups for both serious and non-serious cases.
      • Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs.

    • Compliance and Data Entry:

      • Ensure accurate and timely data entry into the safety database, adhering to client guidelines and global regulatory standards.
      • Maintain knowledge of global pharmacovigilance regulations and industry practices.

    • Analysis and Problem Solving:

      • Analyze and resolve lower-complexity issues with a moderate level of instruction.
      • Provide detailed analysis and support for safety data and case management.

    • Collaboration and Communication:

      • Interact with peers within Accenture, providing updates to supervisors as needed.
      • Limited exposure to clients and Accenture management, with a focus on internal team dynamics.

    • Shift Work:

      • Be prepared to work in rotational shifts as required.

    What We Are Looking For:

    • Experience: 3 to 5 years in pharmacovigilance or drug safety.
    • Skills:
      • Proficient in managing and analyzing pharmacovigilance data.
      • Strong attention to detail and compliance with regulatory requirements.
      • Ability to work effectively within a team and handle focused tasks.
    • Language Proficiency: N3 JLPT certified, with elementary Japanese language skills.
    • Education: Bachelor’s or Master’s degree in Pharmacy.
    • Flexibility: Willingness to work in rotational shifts.

    Additional Requirements:

    • Background or work experience in life sciences is desirable.
    • Knowledge of translation processes and documentation.

    Join us to contribute to life-saving pharmacovigilance efforts and enhance patient safety globally.

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