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    Sr Specialist Aggregate Safety Process

    Organon
    1+ years
    Not Disclosed
    Belgrade Mumbai
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Aggregate Safety Process, Sr. Specialist

    Position Overview

    Location: Remote/Onsite options available
    Job Type: Regular
    Travel Requirements: Must meet applicable travel and credentialing requirements, including vaccination prerequisites.
    Relocation: Not provided.
    Reports To: Aggregate Safety Reporting Team

    The Aggregate Safety Process, Sr. Specialist ensures the high-quality and compliant reporting of aggregate safety reports in line with global pharmacovigilance (PV) regulations. This role involves performing quality reviews, compliance monitoring, and providing support for inspection readiness activities. The Sr. Specialist also collaborates with internal and external stakeholders to address quality and compliance challenges.

    Key Responsibilities

    1. Aggregate Safety Report Quality Review and Compliance

      • Conduct quality reviews and monitor compliance for aggregate safety reports submitted to Health Authorities and Business Partners.
      • Ensure compliance with PV regulations, internal standards, and timelines.
      • Track and evaluate metrics and key performance indicators to measure quality and compliance effectiveness.

    2. Data Management and Quality Control

      • Extract, calculate, and conduct quality checks on patient exposure data for aggregate reports.
      • Maintain tools and processes to streamline data monitoring and introduce automation where applicable.

    3. Stakeholder Collaboration and Problem Solving

      • Collaborate with internal teams and external stakeholders to address and resolve quality and compliance issues.
      • Support the development and implementation of solutions to minimize risk and maintain high reporting standards.

    4. Regulatory and Procedural Updates

      • Incorporate emerging regulatory requirements to ensure global alignment of quality and compliance activities.
      • Assess and adapt processes based on internal procedural changes to maintain relevance and effectiveness.

    5. Inspection Readiness and Training

      • Participate in inspection readiness activities, including preparation and response to regulatory agency questions.
      • Assist in developing training materials and mentoring new team members on aggregate safety processes.

    6. Continuous Improvement and Initiative Participation

      • Engage in pharmacovigilance process improvements and IT initiatives to enhance operations.
      • Contribute to the continuous improvement of quality review processes and aggregate safety operations.

    Required Education, Experience, and Skills

    Education:

    • Bachelor’s or Master’s degree in life sciences, healthcare, or pharmaceutical-related fields.

    Experience and Skills:

    • Strong knowledge of PV principles, regulations, and systems.
    • Analytical mindset with a focus on quality, attention to detail, and compliance.
    • Effective problem-solving, critical thinking, and conflict resolution abilities.
    • Proficiency in Office 365 applications and data management tools.
    • Excellent English written and verbal communication skills.
    • Ability to prioritize tasks, multitask effectively, and manage competing priorities.
    • Strong collaboration and relationship-building skills in cross-functional environments.
    • Ability to analyze process data, metrics, and KPIs.

    Preferred Qualifications

    • Experience with IT tools for PV reporting processes.
    • Familiarity with automation in quality monitoring and compliance activities.

    About Organon

    Organon is a global healthcare company committed to improving health outcomes with a focus on women’s health. By expanding access to leading biosimilars and addressing unmet health needs, Organon aims to deliver impactful health solutions worldwide.

    Employment Notes

    • Diversity Commitment: Organon is an equal opportunity employer dedicated to fostering an inclusive environment.
    • Search Firm Policy: Unsolicited referrals without prior written agreements will not be accepted.

    For more information on Equal Employment Opportunity rights, please review:

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