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    Drug Safety Reporting Senior

    Thermo Fisher Scientific
    8+ years years
    Preffered by Company
    Remote
    Not Disclosed May 13, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: ICSR Case Processing

    Drug Safety Reporting Senior

    Location: Remote, India
    Job ID: R-01237756
    Job Type: Full-time
    Category: Clinical Research
    Remote: Fully Remote

    Job Description

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our mission to enable our customers to make the world healthier, cleaner, and safer. We provide resources to help our teams achieve career goals while advancing science through research, development, and delivery of life-changing therapies. With clinical trials conducted in over 100 countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital, and decentralized clinical trial services.

    Discover Impactful Work

    As a Drug Safety Reporting Senior, you will be responsible for the overall planning, coordination, and delivery of safety reporting for large and complex projects. You will lead these projects and programs, ensuring full oversight, maintenance of metrics, compliance, and finances. Your role will also include recommending updates to procedures, regulatory intelligence activities, and other initiatives related to safety reporting. You will provide training and support to team members and serve as the primary point of contact in the absence of the manager.

    A Day in the Life

    • Receive, prepare, and submit safety reports to applicable parties, ensuring compliance at all stages.
    • Identify and resolve any quality or timeline issues, keeping the manager informed of progress.
    • Exercise independent judgment to troubleshoot and resolve project issues and identify areas for improvement.
    • Lead and monitor large and complex projects to ensure successful and timely completion.
    • Attend and present at various meetings as required.
    • Facilitate and advise on company, client, and regulatory audits where required.
    • Provide training and support to lower-level team members, mentor new starters, and provide input on individual performance.
    • Work with the manager to collate and analyze compliance metrics and provide recommendations on updating financial systems.

    Keys to Success

    Education

    • Bachelor's degree

    Experience

    • Previous experience (comparable to 8+ years) that provides the knowledge, skills, and abilities to perform the job, or an equivalent combination of education, training, and experience.

    Knowledge, Skills, Abilities

    • Advanced knowledge of medical terminology
    • Excellent Microsoft Office skills and understanding of database functionality
    • Thorough understanding of global safety reporting requirements and procedural documents
    • Excellent critical thinking and problem-solving abilities
    • Demonstrated ability to lead, mentor, and motivate others
    • Ability to work well in a collaborative team environment
    • Strong attention to detail with the ability to work with ambiguity and complexity
    • Demonstrated initiative and the ability to apply persuasion and negotiation skills to complete tasks
    • Ability to communicate and assist internal clients effectively

    Our Mission

    Our mission is to enable our customers to make the world healthier, cleaner, and safer. Join us as our colleagues explain five reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values: Integrity, Intensity, Innovation, and Involvement. Together, we accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.

    Equal Opportunity Employer

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

    Accessibility/Disability Access

    Thermo Fisher Scientific offers accessibility services for job seekers requiring accommodations in the job application process. If you need assistance due to a disability, please contact us at 1-855-471-2255. Include your contact information and specific details about your required accommodation to support you during the job application process.

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