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    Aggregate Safety Process, Senior Specialist

    Organon
    2+ years
    Not Disclosed
    Mumbai
    10 Nov. 15, 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

    Position: Aggregate Safety Process, Sr. Specialist

    Overview:
    As an Aggregate Safety Process Sr. Specialist, you will ensure high-quality and compliant reporting of aggregate safety reports in accordance with Pharmacovigilance (PV) regulations, ensuring the integrity of aggregate safety reports while maintaining regulatory compliance.

    Key Responsibilities:

    • Perform quality review and compliance monitoring of aggregate safety reports submitted to Health Authorities and Business Partners, ensuring adherence to regulatory requirements.
    • Measure and track quality effectiveness using key performance indicators (KPIs) and other relevant metrics.
    • Extract, calculate, and conduct quality control (QC) of patient exposure data for aggregate reports.
    • Monitor the quality of aggregate safety reports to ensure internal and regulatory compliance.
    • Collaborate with internal and external stakeholders to identify, prioritize, and address quality and compliance issues, developing solutions to mitigate risks.
    • Implement emerging regulations to ensure global alignment with quality and compliance activities.
    • Assess the impact of procedural changes on quality and compliance monitoring activities, updating processes as needed.
    • Participate in critical pharmacovigilance, IT, and quality initiatives.
    • Maintain procedural documents related to quality review and compliance activities.
    • Assist with inspection readiness and preparation as required.
    • Support the review of regulatory agency responses regarding quality and compliance monitoring.
    • Develop and maintain tools for streamlining quality and compliance monitoring, implementing automation where possible.
    • Provide training and support to new team members.
    • Manage Aggregate Report operations and mailbox.
    • Contribute to continuous improvement efforts within the process.

    Required Qualifications:

    • Bachelor’s or Master’s degree in life sciences, healthcare, or pharmaceutical-related fields.
    • In-depth knowledge of PV principles, systems, and regulatory requirements.
    • Strong analytical skills with a focus on quality and compliance.
    • Excellent problem-solving, conflict resolution, and critical thinking abilities.
    • Ability to work autonomously, manage competing priorities, and adapt to changing business needs.
    • Proficiency in Office 365 applications.
    • Strong written and verbal English communication skills.
    • Highly organized with attention to detail and multitasking capabilities.
    • Proficient in Microsoft Office and relevant IT tools for assigned processes.
    • Ability to collaborate effectively and build relationships in a cross-functional environment.

    About Us:
    Organon is a global healthcare company committed to delivering health solutions that enable individuals to live their best lives. We focus on improving the health and well-being of women and their communities, driving innovation in women’s health and biosimilars.

    Employment Details:

    • Employee Status: Regular
    • Relocation: No relocation provided
    • Visa Sponsorship: Not offered
    • Travel Requirements: Must meet credentialing and vaccination requirements for applicable travel.

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