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    Job · 16574090

    Accenture logo

    Pharmacovigilance Services Analyst

    Accenture · Chennai · onsite · Posted 42d ago

    Undisclosed3–5 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Skill required: Pharmacovigilance Operations - Safety Writing
    Designation: Pharmacovigilance Services Analyst
    Qualifications:Bachelor of Pharmacy
    Years of Experience:3 to 5 years

    Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Songall powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries.
    What would you do Use scientific expertise to develop high-quality medical scientific content outlines and guide the team in content development for assigned modules projects in line with client expectations.Collaborate with cross-functional teams to support the medical legal regulatory (MLR) review process, respond to MLR review committee queries, and implement required changes effectively.Management of the Affiliate Mailbox reconciliation of reports per process and performance of all written follow up attempts to include both Serious and Non serious casesManage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for completed interim clinical study reports.
    What are we looking for Primary skill - Safety Writing - P5 Bachelor s or masters degree in pharmacy life sciences.1.5 - 3 years of experience in reviewing medical documents Medical referencing.Proficiency in medical referencing techniques and awareness of industry standards.Exhibit proficiency in MS Office applications, including Excel, Adobe Acrobat, Outlook, and PowerPoint.Strong organizational skills and attention to detail.Effective interpersonal and communication skills.Ability to work well in a dynamic team environment.Experience with Veeva Vault PromoMats Vault ProMotion is preferr
    Roles and Responsibilities: Use scientific expertise to develop high-quality medical scientific content outlines and guide the team in content development for assigned modules projects in line with client expectations.Collaborate with cross-functional teams to support the medical legal regulatory (MLR) review process, respond to MLR review committee queries, and implement required changes effectively.Experience in writing white papers, manuscripts, point of view, etc.Write scientific content for projects if the nature of the project is extremely complex and it requires expertise or based on business need.Communicate the clinical data in a clear and concise manner.Follow department best practices for processes, communication, project management, documentation, and technical requirements.Converts relevant data and information into a form that meets regional regulatory requirements.Understands and complies with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs to comply with regulatory requirements.Completes assignments independently or for more complex documents, under the guidance of a mentor.Ensure compliance with client and Accenture internal SOPs for all materials.Collaborate with technology and creative teams to develop innovative digital solutions.Ensure quality delivery and client engagement for organic growth


    Qualification
    Bachelor of Pharmacy

    Sourced from naukri

    Skills

    HashiCorp Vaultms office applicationsclinical datapharmacovigilanceregulatory submissionsVeeva vaultPharmacyDigital SolutionsProject ManagementCommunication SkillsoperationsLegalcomplianceLife Sciences

    About Accenture

    Accenture logo

    Accenture

    IT Services & Consulting

    350k+

    employees

    1989

    37 years old

    Dublin

    Ireland

    About

    Accenture plc is an Irish-American, professional services company based in Dublin, specializing in information technology services and consulting.

    Industries

    IT Services & ConsultingAnalytics & KPOSoftware ProductManagement Consulting

    Employee ratings

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