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    Safety Writer

    Thermo Fisher Scientific
    0-5 years
    Not Disclosed
    Remote, USA
    12 June 3, 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, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Opportunity: Safety Writing Services Coordinator

    Summarized Purpose: Responsible for planning, coordinating, and delivering safety writing services for multiple clinical trials and/or marketed product projects. This role involves day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. The scope includes delivering low complexity safety writing tasks, such as project management, data review, authoring, and quality review. May also support authoring of medium complexity deliverables. Effective collaboration with various stakeholders, including PVG project team members, PPD/Evidera project team members, client contacts, and third-party vendors, is essential.

    Essential Functions:

    • Data Review and Authoring: Conducts data review, authoring, and quality review tasks for a range of low complexity clinical trial and marketed product safety writing deliverables (e.g., line listing reports, Periodic Adverse Drug Experience Reports (PADERs)).
    • Medium Complexity Deliverables: May support authoring of medium complexity deliverables (e.g., Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), development Risk Management Plans (dRMPs)) under supervision from senior staff.
    • System Usage: Utilizes multiple company and client systems; interacts with project team members and clients.
    • Lead Capacity: Operates in a lead capacity, serving as the primary point of contact for assigned low complexity safety writing deliverables.
    • Compliance: Ensures tasks are conducted in accordance with company policies, procedures, contractual agreements, and applicable regulations.
    • Regulatory Updates: Reviews regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, and procedures.
    • Project Implementation: Manages routine project implementation and coordination, including managing communications and data requests, and participating in kick-off meetings, client meetings, audits, and inspections.

    Education and Experience:

    • Degree: Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
    • Experience: Previous experience (comparable to 2+ years) that provides the knowledge, skills, and abilities to perform the job. In some cases, a combination of education, training, and directly related experience will be considered sufficient.

    Knowledge, Skills, and Abilities:

    • Regulatory Knowledge: Good knowledge of ICH and US aggregate safety reporting formats relating to clinical trials and/or marketed products.
    • Attention to Detail: Strong attention to detail with good data interpretation and medical-scientific writing skills.
    • Critical Thinking: Solid critical thinking and problem-solving skills with the ability to escalate issues appropriately.
    • Task Management: Ability to manage and prioritize a variety of tasks and meet strict deadlines with modest supervision.
    • Communication Skills: Effective oral and written English communication skills, including paraphrasing skills.
    • Technical Skills: Good computer skills with the ability to work within multiple systems; proficient in Microsoft Office products (including Outlook, Word, and Excel).
    • Regulatory Understanding: Good understanding of global regulatory requirements pertaining to pharmacovigilance and the importance of and compliance with procedural documents and regulations.
    • Professionalism: Ability to maintain a positive and professional demeanor in challenging circumstances.
    • Teamwork: Ability to work effectively within a team to attain a shared goal.

    For more information and to apply, please visit our Careers Page. Join our team and contribute to delivering top-tier safety writing services in a dynamic and regulated environment.

     

     

     

     

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