Safety Process Specialist

1 day ago

Mumbai, Maharashtra, India Lifelancer Full time

About Organon

">We are a global healthcare company focused on making a world of difference for women, their families and the communities they care for.

Our Vision

">A better and healthier every day for every woman.

Job Title: Sr Specialist Aggregate Safety Process

">This role is perfect for someone who wants to work in Pharmacovigilance and has experience in quality review and compliance monitoring of aggregate safety reports.

Job Description

">
  • ">
  • The Position:">
    • ">
    • Maintains and performs necessary processes to ensure high quality and compliant reporting of aggregate safety reports in accordance with PV regulations.">
    • Performs quality review and compliance monitoring of aggregate safety reports to Health Authorities and Business Partners adhering to regulatory requirements.">
    • Responsible for extracting, calculating and overall QC of patient exposure for aggregate reports.">
    • Monitors the quality of aggregate safety reports and compliant reporting to ensure internal and regulatory compliance.">
    • Partners with internal and external stakeholders to identify, prioritize and monitor quality and compliance issues and develop solutions to minimize risk and ensure the overall quality of aggregate safety reports.">
    • Extracts, calculates and quality reviews patient exposure data.">
    • Implements emerging regulations to ensure global alignment of quality and compliance activities and processes.">
    • Assesses the impact of internal procedural changes to quality and compliance monitoring activities and updates these activities to remain relevant.">
    • Participates in various important pharmacovigilance processes, IT and quality initiatives.">
    • Maintains procedural documents relevant to quality review and compliance.">
    • Participates in inspection readiness activities and preparation as needed.">
    • Assists in the review of responses to regulatory agency questions with regards to quality and compliance monitoring activities.">
    • Develops and maintains tools to streamline the monitoring of quality and compliance, introducing automation where possible.">
    • Provides training and support to new team members.">
    • Manages Aggregate Report operations of mailbox.">
    • Contributes to continuous improvement efforts in the process.">
    ">
  • Required Skills and Qualifications">
    • ">
    • Bachelor's degree or Master's degree in a life science/health care/pharmaceutical related field.">
    • Knowledge of PV principles, systems, and requirements in addition to PV regulations.">
    • Strong analytical skills and quality focus.">
    • Problem-solving, conflict resolution, and critical thinking skills.">
    • Ability to function with a high degree of autonomy, quickly adapt to changes in business priorities, and effectively manage competing priorities.">
    • Proficient in basic Office 365 suite applications.">
    • Strong English written and verbal communication skills.">
    • Ability to organize and multi-task with attention to detail.">
    • Strong working knowledge of Microsoft Office and IT tools used for assigned process.">
    • Analytical skills to manage process data, metrics, and KPIs.">
    • Ability to collaborate well with others and develop effective relationships, motivate, and influence in a cross-functional environment.">
    ">

Benefits

">Lifelancer offers a competitive salary range between $80,000 - $110,000 per annum, based on experience.

Location

">The role is located in Mumbai, Maharashtra, India.

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