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    Pharmacovigilance Services Analyst

    Accenture
    3-5 years
    Not Disclosed
    Bengaluru
    10 Dec. 19, 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 Title: Pharmacovigilance Services Analyst
    Location: [Location not provided]

    About Accenture:
    Accenture is a global professional services company with leading capabilities in digital, cloud, and security. With over 699,000 people across more than 120 countries, Accenture provides services in Strategy, Consulting, Technology, and Operations, powered by advanced technology and intelligent operations centers. We create value and success for our clients, people, shareholders, and communities. Visit us at www.accenture.com.

    Job Overview:
    As a Pharmacovigilance Services Analyst, you will be responsible for managing and processing pharmacovigilance and drug safety data, ensuring compliance with global regulatory requirements. You will assist in case intake, follow-up, submission to regulatory authorities, and performing quality checks on adverse event reports.

    Key Responsibilities:

    • Manage the Affiliate Mailbox and reconcile reports according to process.
    • Perform follow-up attempts for both Serious and Non-serious cases.
    • Handle verbal follow-ups for countries where English is the primary language of communication.
    • Address queries from the global case processing team or other sources related to source documents or follow-up information.
    • Create and manage case identification, data entry, MedDRA coding, case processing, and submission of Individual Case Safety Reports (ICSRs) in the safety database.
    • Ensure compliance with client guidelines and applicable global regulatory requirements.
    • Conduct quality checks such as source data verification and free text review according to client Standard Operating Procedures (SOPs).
    • Perform duplicate searches and acknowledge ICSR receipt to the sender.
    • Submit cases to local regulatory authorities as per guidelines.
    • Follow up with reporters for additional information as needed.
    • Download cases from Health Authority portals for reconciliation.
    • Provide analysis and solutions to lower-complexity problems.
    • Limited interaction with clients or Accenture management, primarily collaborating with peers.

    Qualifications:

    • Education: BSc or Bachelor of Pharmacy (B.Pharm).
    • Experience: 3 to 5 years in pharmacovigilance or drug safety.
    • Skills:
      • Strong communication skills, both written and verbal, in English.
      • Ability to work under pressure and meet deadlines.
      • Strong attention to detail and adaptability.
      • Comfortable communicating with US citizens.
      • Knowledge of pharmacovigilance, ICSR processing, and MedDRA coding.
      • Ability to perform quality checks and adhere to regulatory requirements.
      • Comfortable working in rotational shifts.

    What We Are Looking For:

    • Adaptability and flexibility in a dynamic environment.
    • Strong problem-solving and analytical skills.
    • Ability to perform under pressure and handle routine tasks.
    • Excellent written and verbal communication in English.

    Work Environment:

    • This role may require working in rotational shifts.

    Apply Now:
    For more information, visit Accenture Careers.

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