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    Medical Reviewer - Aggregate Report

    Sitero
    2+ years
    Not Disclosed
    Mysore
    10 Oct. 30, 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

    Company Overview:

    Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. With expertise in a diverse range of therapeutic areas, we focus on innovative, technology-enabled solutions that empower our clients to concentrate on their core strengths. From early phase studies to Phase III clinical trials, our experienced team ensures the safety of all stakeholders in the clinical research community, prioritizing ethics, compliance, and innovation.

    Job Title: Medical Reviewer

    Location: Mysore (Hybrid)

    Function: Drug Safety

    Job Description:

    The Medical Reviewer serves as the key contact for assigned clinical development or marketed products, responsible for safety strategy and major safety deliverables in both early and late-stage development. This role involves managing safety and risk management activities, conducting cross-functional assessments of the benefit-risk profile, and communicating safety information for assigned products. The individual will collaborate closely with safety teams in Contract Research Organizations (CROs) and partners, maintaining a strong and current knowledge of drug safety and pharmacovigilance regulations.

    Essential Duties and Responsibilities:

    • Lead Pharmacovigilance (PV) and risk management activities.
    • Coordinate post-marketing regulatory reporting and PV activities with the aggregate reporting team.
    • Assess data for product-specific reports and draft all individual, aggregate, and cumulative medical assessments.
    • Provide medical oversight in drafting reports in accordance with approved Standard Operating Procedures (SOPs).
    • Review finalized reports to ensure adherence to quality standards.
    • Offer expert guidance in Pharmacovigilance and aggregate reporting domains.
    • Contribute medical content for Aggregate Safety Reports (e.g., PSUR, PBRER, RMP).
    • Prepare and review responses to ad hoc regulatory queries.
    • Scientifically interpret data for drug safety documents and prepare analytical aggregate reports.
    • Collaborate with internal teams to address issues beyond standard responsibilities.
    • Serve as a subject matter expert for vendors in drug safety and pharmacovigilance services.
    • Train and mentor Pharmacovigilance Physicians and Specialists.
    • Maintain accurate records of report completion and submission dates.

    Other Responsibilities:

    • Familiarize and adhere to organizational SOPs.
    • Collaborate with colleagues to address challenges and identify process improvements.
    • Support team members in achieving their objectives.
    • Perform any other duties as required.

    Education and Experience Required:

    • 1-3 years of clinical practice experience.
    • 1+ year in Drug Safety and Pharmacovigilance within a pharmaceutical, biotech company, CRO, or regulatory agency.
    • Medical Degree (MBBS or higher) from a recognized medical school.

    Preferred Skills:

    • Knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines.
    • Experience in medical drug safety assessments and monitoring activities.
    • Strong interpersonal skills for collaboration and influence across disciplines.
    • Excellent verbal, written, and presentation skills.
    • Innovative and proactive approach.

    Compensation & Benefits:

    Sitero offers a competitive salary, variable pay, paid time off, and comprehensive healthcare and retirement benefits.

    Employment Type:

    Permanent, Full Time

    Commitments:

    • Standard hours: 40 hours per week, Monday – Friday, with a one-hour lunch.
    • Willingness to work shifts as needed.

    Disclaimer:

    Sitero is an equal opportunity employer. We welcome all job applicants and ensure that all qualified applicants receive consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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