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Pspm Senior Support Associate

2+ years
Not Disclosed
10 Nov. 6, 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 Opportunity: MIS & Reporting Specialist at Fortrea

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 employees conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients around the globe.

Job Description:

We are seeking a detail-oriented MIS & Reporting Specialist who will be responsible for driving the efficiency, accuracy, and timeliness of reports and dashboards across multiple departments. This role will focus on PowerPoint automation, data analysis, report generation, and tool implementation to enhance data visualization and reporting within our organization. The ideal candidate will collaborate with various departments to ensure accurate and actionable insights from the data, contributing to the smooth functioning of our global clinical trials and safety projects.

Key Responsibilities:

  • Report Management: Ensure the efficiency, accuracy, and timely delivery of reports and dashboards across the organization.
  • PowerPoint Automation: Develop MS PowerPoint automations to analyze trends, performance, and actions, which will assist senior management in decision-making.
  • Data Analysis: Analyze data trends to provide actionable insights and ensure alignment with project goals.
  • Collaboration: Work closely with various departments to gather and analyze data for more informed decision-making.
  • Tool Implementation: Implement and maintain reporting tools and dashboards for enhanced data visualization.
  • MIS Systems: Design, develop, and maintain Management Information Systems (MIS) to meet organizational needs.
  • Global Safety Support: Provide ongoing support for the setup, maintenance, and closure of global or regional clinical trial and post-marketing safety studies.
  • Safety Documentation: Support the preparation of safety-specific plans, including Safety Management Plans (SMPs) and Reconciliation Plans.
  • Project Reporting: Generate and maintain status reports on global safety projects, ensuring quality and accuracy of data and metrics.
  • Training & Documentation: Assist with training activities, safety documentation for audits, and ensuring that project deadlines are met.
  • System Knowledge: Maintain a thorough understanding of Fortrea’s safety database conventions and ensure compliance with global safety reporting standards.
  • Audit Support: Assist in preparing safety documentation for regulatory audits.

Required Experience and Qualifications:

  • Experience: Minimum 5+ years of relevant experience in Management Information Systems (MIS), ideally within the Contract Research Organization (CRO) or clinical trial sector.
  • Education: Bachelor's or Master’s degree (preferably in a life sciences field).
  • Technical Skills: Knowledge of tools such as PowerBI, SQL, and proficiency in PowerPoint automation are highly desirable.
  • Location: Bangalore, India.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual, without discrimination on the basis of race, religion, gender, disability, veteran status, sexual orientation, gender identity, or any other legally protected characteristic.