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    Pharmacovigilance Services Associate

    Accenture
    1-3 years
    Not Disclosed
    Mumbai
    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 Associate

    Skill Required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance

    Designation: Pharmacovigilance Services Associate

    Qualifications: Bachelor’s or Master’s in Pharmacy

    Years of Experience: 1 to 3 years

    About Accenture:

    Accenture is a leading global professional services company with expertise in digital, cloud, and security. We offer Strategy and Consulting, Technology and Operations services, and Accenture Song, leveraging the world's largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 employees deliver technology and human ingenuity every day, serving clients in over 120 countries. We drive change to create value and shared success for our clients, people, shareholders, partners, and communities. Learn more at www.accenture.com.

    Role Overview:

    As a Pharmacovigilance Services Associate, you will be a key player in our Life Sciences R&D vertical. Your role will involve supporting pharmacovigilance and drug safety surveillance, particularly in managing case identification, data entry, MedDRA coding, case processing, and follow-up for Individual Case Safety Reports (ICSRs) in the safety database. This role requires adherence to client guidelines and global regulatory requirements.

    Key Responsibilities:

    • Case Management:

      • Manage the Affiliate Mailbox, handle reconciliation of reports per process, and perform written 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 entry of case data into the safety database according to client guidelines and regulatory requirements.
      • Maintain up-to-date knowledge of global pharmacovigilance regulations and standards.

    • Routine Problem Solving:

      • Solve routine issues largely through established guidelines and precedents.
      • Interact primarily within your team and with your direct supervisor.

    • Instructions and Decision Making:

      • Receive detailed to moderate level of instruction on daily tasks and new assignments.
      • Make decisions that impact your own work within a defined scope.

    • Team Contribution:

      • Work as an individual contributor within a team, focusing on predetermined tasks.

    • Shift Work:

      • Be prepared to work in rotational shifts if required.

    What We Are Looking For:

    • Experience: 1 to 3 years in pharmacovigilance or drug safety.
    • Skills:
      • Strong understanding of pharmacovigilance and drug safety operations.
      • Proficiency in case management, data entry, and MedDRA coding.
      • Ability to follow detailed instructions and solve routine problems.
      • Effective communication skills and attention to detail.
    • Education: Bachelor’s or Master’s degree in Pharmacy.
    • Flexibility: Willingness to work in rotational shifts as needed.

    Join us to contribute to life-saving work and help shape the future of patient safety and pharmacovigilance.

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