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    Junior Data Analyst

    Cognizant
    0-2 years
    Preffered by Company
    Mumbai
    10 Aug. 29, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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 Summary

    We are looking for a skilled Senior Process Executive for Clinical Data Management (CDM) and Pharmacovigilance (PV) with 2 to 3 years of relevant experience. The ideal candidate will have a strong background in MS Excel and PV case processing. This role involves managing pharmacovigilance cases to ensure regulatory compliance and supporting research and development efforts.

    Responsibilities

    • Case Management: Handle and process pharmacovigilance cases to ensure compliance with all regulatory requirements.
    • Data Entry: Accurately and promptly enter data into the PV database.
    • Reporting: Assist in preparing safety reports and regulatory submissions.
    • Cross-Functional Collaboration: Work with cross-functional teams to verify the accuracy and completeness of case information.
    • Data Analysis: Utilize MS Excel for analyzing and reporting on pharmacovigilance data.
    • Quality Assurance: Ensure adherence to standard operating procedures and guidelines, conducting quality checks to maintain high standards.
    • Process Improvement: Contribute to the development and implementation of process improvements.
    • Training and Development: Participate in training to stay updated on regulatory changes and industry best practices.
    • Research Support: Provide insights and support for research and development initiatives.
    • Complex Case Handling: Assist the team with complex cases and issue resolution.
    • Regulatory Knowledge: Keep current with pharmacovigilance regulations and guidelines.
    • Stakeholder Communication: Communicate effectively with stakeholders to ensure clarity and accuracy in PV processes.

    Qualifications

    • PV Case Processing Expertise: Strong understanding of pharmacovigilance case processing and regulatory requirements.
    • Excel Proficiency: Advanced skills in MS Excel for data analysis and reporting.
    • R&D Experience: Experience in research and development is a plus.
    • Attention to Detail: Excellent attention to detail and accuracy in data entry and case processing.
    • Organizational Skills: Strong organizational and time management skills.
    • Communication and Collaboration: Effective communication and collaboration abilities.
    • Proactive Problem-Solving: A proactive approach to problem-solving and process improvement.
    • Continuous Learning: Commitment to staying updated with industry trends and regulatory changes.
    • Team Player: Ability to work both independently and as part of a team.
    • Quality Focus: Dedicated to maintaining high-quality standards in all tasks.
    • Experience: 2 to 3 years of relevant experience in PV case processing.
    • Educational Background: Degree in life sciences or a related field.

    Certifications Required

    • Certification: Certified Pharmacovigilance Professional (CPP) or equivalent certification in pharmacovigilance.

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