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    Medical Reviewer - Aggregate Report

    Sitero
    1-3 years
    Preffered by Company
    Mysore
    10 Aug. 26, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any 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. We specialize in a diverse range of therapeutic areas and focus on delivering innovative, technology-enabled solutions that enable our clients to excel in their core strengths. Our experienced team provides comprehensive services and advanced technology for early phase through Phase III clinical trials, ensuring the safety of all stakeholders while emphasizing ethics, compliance, and innovation.

    Job Title: Medical Reviewer

    Location: Mysore - Hybrid

    Function: Drug Safety

    Position Overview

    As a Medical Reviewer at Sitero, you will be a pivotal figure in managing safety strategies and deliverables for assigned clinical development or marketed products. This role involves overseeing safety and risk management activities, conducting benefit-risk assessments, and ensuring effective communication of safety information. You will work closely with safety teams at Contract Research Organizations (CROs) and other partners, requiring a deep understanding of drug safety, pharmacovigilance regulations, and risk management practices.

    Essential Duties and Responsibilities

    • Lead pharmacovigilance (PV) and risk management activities across all aspects.
    • Coordinate post-marketing regulatory reporting and PV activities with the Sitero aggregate reporting team.
    • Assess relevant data for product-specific reports.
    • Draft and oversee medical assessments and benefit-risk evaluations for safety reports.
    • Provide medical oversight in report drafting following approved SOPs and Work Instructions (WIs).
    • Manage internal review processes and finalize reports from a medical perspective.
    • Assist medical writers with client feedback and finalize reports accordingly.
    • Review finalized reports to ensure adherence to quality standards.
    • Offer expert guidance in PV and aggregate reporting domains.
    • Contribute to Aggregate Safety Reports (PSUR, PBRER, PADER, Summary Bridging Report, Addendum to Clinical Overview, DSUR, RMP, and addendum to PSUR).
    • Prepare and review responses to ad hoc regulatory queries.
    • Scientifically interpret data for drug safety documents and prepare analytical aggregate reports.
    • Ensure all documents adhere to SOPs, conventions, and regulatory requirements.
    • Plan and manage daily activities to meet service-level timelines and deliverables.
    • Collaborate with the Sitero Aggregate Reporting team lead to address complex issues.
    • Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
    • Train and mentor Pharmacovigilance Physicians and Specialists.
    • Maintain accurate records of report completion and submission dates.

    Additional Responsibilities

    • Adhere to organizational SOPs and assist in setting and reinforcing departmental standards.
    • Collaborate with colleagues to address challenges and explore innovative ways to improve processes.
    • Support team members in achieving their objectives and perform other duties as assigned.

    Education and Experience Required

    • 1-3 years of clinical practice experience required.
    • 1+ year of experience in Drug Safety and Pharmacovigilance within a pharmaceutical or biotech company, CRO, or regulatory agency, with exposure to both investigational and marketed products preferred.
    • 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, surveillance, and monitoring activities.
    • Ability to build relationships, collaborate, and influence across disciplines.
    • Excellent verbal, written, and presentation skills.
    • Innovative, collaborative, and proactive approach to problem-solving.

    Compensation & Benefits

    Sitero offers a competitive compensation package, including 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 break. Additional hours as needed.
    • Willingness to work shifts as required.

    Disclaimer

    Sitero is an equal opportunity employer. We welcome all qualified applicants regardless of 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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