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    Pharmacovigilance Services Specialist

    Accenture
    7-10 years
    Not Disclosed
    Bangalore
    10 Nov. 21, 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 Specialist

    Skill Required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance
    Designation: Specialist
    Qualifications: Any Graduation
    Years of Experience: 7 to 10 years

    About Accenture

    Accenture is a global professional services company with leading capabilities in digital, cloud, and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song—all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners, and communities. Visit us at www.accenture.com.

    What Would You Do?

    • Be overall responsible for managing the PSUR (Periodic Safety Update Reports) team at ESP.
    • Track stages and milestones of aggregate reports according to predefined schedules.
    • Follow the escalation process as per client guidelines.
    • Ensure the training and mentoring of new aggregate reporting associates, documenting progress accordingly.
    • Address quality-related issues and implement continuous quality improvement initiatives for the team.
    • Provide delivery updates during monthly operation steering committee meetings.
    • Ensure retention and project compliance as per client SOPs.
    • Timely generation of RCA-CAPA (Root Cause Analysis and Corrective and Preventive Actions) for any deviations in SLA/SOP.
    • Manage the Affiliate Mailbox, reconcile reports per process, and ensure performance of all follow-up attempts for both serious and non-serious cases.
    • Manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs (Individual Case Safety Reports) in the safety database in compliance with client guidelines and global regulatory requirements.

    What Are We Looking For?

    Educational Requirement:

    • Medical Degree (MBBS)
    • Bachelor’s Degree in Pharmacy
    • Advanced Nursing Degree
    • Master’s Degree in Life Sciences

    Work Experience Requirement:

    • Prior experience in managing service delivery, preferably in pharmacovigilance or clinical data management functions.

    Roles and Responsibilities:

    • Analyze and resolve moderately complex problems.
    • Create new solutions by leveraging and adapting existing methods and procedures as necessary.
    • Understand the strategic direction set by senior management in relation to team goals.
    • Interact primarily with your direct supervisor or team leads, while also collaborating with peers and/or management at a client or within Accenture.
    • Work with minimal guidance when determining methods and procedures for new assignments.
    • Make decisions that impact the team and occasionally other teams.
    • Manage medium-small sized teams and/or work efforts, either in an individual contributor or leadership role.
    • Note: This role may require you to work in rotational shifts.

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