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    Medical Reviewer - Aggregate Report

    Sitero
    1-3 years
    Not Disclosed
    Mysore
    10 Aug. 7, 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, 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

    Job Title: Medical Reviewer - Drug Safety

    Location: Mysore (Hybrid)

    Function: Drug Safety

    Company Overview:

    Sitero is a leading provider of clinical services and software solutions for the life sciences industry. With expertise across various therapeutic areas, we focus on innovative, technology-driven solutions that enable our clients to concentrate on their core strengths. Our experienced team delivers high-touch services and technology for clinical trials, ensuring stakeholder safety with an emphasis on ethics, compliance, and innovation.

    Job Description:

    As a Medical Reviewer, you will be the key contact for assigned clinical development or marketed products, overseeing safety strategy and major safety deliverables. You will be responsible for safety and risk management activities across both early and late-stage development. Your role will involve managing the benefit-risk profile, coordinating cross-functional assessments, and communicating safety information for assigned products. Collaboration with safety teams in Contract Research Organizations (CROs) and partners is essential.

    Essential Duties and Responsibilities:

    • Pharmacovigilance and Risk Management: Lead pharmacovigilance and risk management activities for assigned products, ensuring compliance with regulations and best practices.
    • Regulatory Reporting: Coordinate post-marketing regulatory reporting and pharmacovigilance activities with the Sitero aggregate reporting team.
    • Medical Assessments: Draft and review individual, aggregate, and cumulative medical assessments and benefit-risk evaluations. Oversee the preparation and finalization of safety reports, ensuring adherence to quality standards.
    • Report Drafting: Provide medical oversight for report drafting following SOPs and Work Instructions. Collaborate with medical writers to address client feedback and finalize reports.
    • Aggregate Safety Reports: Contribute medical content for Aggregate Safety Reports, including PSUR, PBRER, PADER, and others. Prepare responses to regulatory queries and ensure documents meet SOPs and regulatory requirements.
    • Documentation and Record-Keeping: Maintain accurate records of report completion and submission. Plan and manage daily activities to meet service-level timelines.
    • Training and Mentoring: Train and mentor Pharmacovigilance Physicians and Specialists, and serve as a subject matter expert for drug safety and pharmacovigilance services.
    • Continuous Improvement: Identify innovative ways to enhance departmental processes and support team members in achieving their objectives.

    Education and Experience Required:

    • Clinical Practice Experience: 1-3 years in clinical practice required.
    • Drug Safety Experience: At least 1 year of experience in drug safety and pharmacovigilance, preferably in a pharmaceutical, biotech company, CRO, or regulatory agency.
    • Medical Degree: MBBS or higher from a recognized medical school.

    Preferred Skills:

    • Regulatory Knowledge: Good understanding of US and EU drug safety regulations, CIOMS, and ICH guidelines.
    • Experience: Proven experience with medical drug safety assessments and drug safety surveillance.
    • Skills: Strong verbal, written, and presentation skills. Ability to build relationships and collaborate effectively across disciplines.

    Compensation and Benefits:

    Sitero offers a competitive salary and benefits package, including variable pay, paid time off, 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.
    • Shifts: Willingness to work in shifts if required.

    Equal Opportunity Statement:

    Sitero is an equal opportunity employer. We welcome all job applicants and provide 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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