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    Safety Science Specialist

    Fortrea
    3-4 years
    Not Disclosed
    Bangalore
    10 Aug. 23, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

    Fortrea is a premier global Contract Research Organization (CRO) dedicated to scientific excellence with decades of experience in clinical development. We offer comprehensive clinical development, patient access, and technology solutions across more than 20 therapeutic areas to pharmaceutical, biotechnology, and medical device clients. With a team of over 19,000 professionals operating in more than 90 countries, Fortrea is at the forefront of transforming drug and device development for partners and patients worldwide.

    Job Description:

    The following outlines the general responsibilities and expectations for the role, though it is not an exhaustive list of all duties, skills, and responsibilities:

    • Adverse Event Management:

      • Oversee the receipt and processing of adverse event reports, whether spontaneous or solicited from clinical trials.
      • Enter safety data into adverse event databases and tracking systems.
      • Review adverse events for completeness, accuracy, and appropriateness for expedited reporting.
      • Write patient narratives and code adverse events using MedDRA.
      • Assess listedness against applicable labels for marketed products.
      • Identify and collect clinically significant missing information, preparing follow-up correspondence in consultation with medical staff.
      • Ensure cases receive appropriate medical review and are expedited to regulatory agencies and other required parties within necessary timelines.

    • Report Submission and Maintenance:

      • Prepare and submit Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, and Fortrea project personnel within study timelines.
      • Manage the processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), including maintaining adverse event tracking systems and project files.
      • Perform quality reviews or peer reviews of processed reports and assist with trend analysis and actions as needed.

    • Compliance and Documentation:

      • Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), guidance documents, and directives related to safety management and pharmacovigilance.
      • Assist in generating and maintaining PSS metrics and support preparation for client meetings.
      • Prepare and coordinate safety study files for archiving upon project completion.
      • Support root cause analysis and CAPA plan development for identified quality issues and participate in audits and inspections as needed.

    • Training and Relationship Building:

      • Demonstrate core competencies and company values consistently.
      • Build and maintain effective relationships across functional units.
      • Assist in setting up and providing data to Safety Committees/DSMBs as applicable.

    • Additional Duties:

      • Perform any other duties as assigned by management.

    Experience and Qualifications:

    • Required Experience: 3-4 years of relevant experience in safety, including processing AE/SAE reports, generating narratives, working within safety databases, and regulatory submissions.
    • Educational Background: Degree preferred in Biological Sciences, Pharmacy, Nursing, Life Sciences, Chemistry, or a related field.
    • Relevant Experience: Experience in the pharmaceutical, biotechnology, or CRO industry, including roles in Medical Affairs, Clinical Data Entry, Clinical Data Management, Clinical Monitoring, Regulatory Affairs, or Quality Assurance.

    Location: Bangalore

    Why Join Fortrea?

    Fortrea seeks innovative, solution-oriented individuals who are passionate about overcoming challenges in clinical trials. We are committed to revolutionizing the development process to ensure rapid delivery of life-changing therapies. Join our dynamic team to experience a collaborative work environment where personal growth is encouraged, enabling you to make a global impact. For more information, visit www.fortrea.com.

    Equal Opportunity Employer:

    Fortrea is an Equal Opportunity Employer committed to diversity and inclusion. We do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family status, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic. We encourage all qualified candidates to apply.

    For details on how we handle your personal data, please review our Privacy Statement.

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