Medical Reviewer

7 months ago


Bengaluru, India Alcon Full time

Job Purpose:
- Perform Medical Safety activities for assigned Alcon projects or products, supporting the identification and comprehensive assessment of safety signals from all sources (clinical development through post-approval lifecycle management and externally).

JOB FUNCTIONS

Essential Functions
- Duties are listed in order of greatest importance. Other responsibilities may be assigned._

Perform medical review of single cases and/or aggregate data involving the assigned product(s). Provide safety input to the clinical and regulatory deliverables, including Investigator's Brochures, study protocols, study reports, clinical overviews, and product registrations. Monitor the clinical safety of assigned products/projects, including adverse events and patient impact from technical complaints from studies, literature, and post-market surveillance. Compile, analyze, and interpret clinical and scientific data from multiple sources; summarize safety trends with supervisory guidance. Prepare literature summaries on special topics to characterize product safety profile and support risk management documents. Support the preparation and maintenance of post-market surveillance plans, periodic safety updates, product labelling and related documents. Support the preparation of health hazard assessments and responses to inquiries from health care authorities, health care professionals, or local affiliates. Support business development and licensing activities, health authority inspections/audits, and market action activities.

QUALIFICATIONS

Minimum Education
- Board-certified medical physician required, or other clinically-qualified professional considered based on therapeutic area experience
- Board-certified ophthalmologist (MD or equivalent) preferred

Preferred Education
- Additional advanced degree in scientific research

Minimum Work Experience
- 3 years of clinical experience post-doctoral
- 3 years of medical device and/or pharmaceutical experience in product development, including 2 years in a medical or safety operations position

Knowledge, Skills and Abilities
- Strong interpersonal, communication (written and verbal), and presentation skills
- Strong organizational and project management skills with proven successes in matrix setting
- Works effectively with other line functions in an international setting
- Demonstrates attention to detail, strategic thinking, and problem solving skills
- Experience with (safety or others) issue management
- Self-motivated, ability to work under pressure, demonstrating initiative and flexibility
- High learning agility, ability to work independently and meet targeted timelines in a team-centric environment
- Prior experience in scientific and technical writing in clinical research or regulated work environment

Preferred:

- User experience of company portfolio or similar products in clinical setting
- Knowledge of applicable industry standards and regulations, e.g., EU MDR, ICH, GCP, GVP

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.


  • Medical Reviewer

    6 days ago


    Bengaluru, India Healthminds Consulting Full time

    **Position: Medical Reviewer**: **Qualification**: MSc/PhD/MD in Biological Sciences or Medical Sciences (as applicable) **Pre-requisites** - Experience as peer reviewer in reputed medical journals. - History of publication in peer-reviewed journals. - Experience in handling a team of 4+ medical writers. - To evaluate the quality, accuracy, and completeness...

  • Medical Reviewer

    7 months ago


    Bengaluru, Karnataka, India Natobotics Technologies Private Limited Full time

    Role -Medical Reviewer Qualification: MBBS/MD only (MCI Certification is not mandate**) Experience Range: 1 to 7 Years Preferred Experience: Minimum of 1-5 years of experience in PV/ Clinical Research (drug safety) Location: Mumbai/ Pune/ Nagpur/ Gandhinagar/ Bangalore/ Chennai/ Indore. Roles & Responsibilities - Author a company clinical comment (CCC)...

  • Medical Reviewer

    7 months ago


    Bengaluru, Karnataka, India Novo Nordisk Full time

    Medical Reviewer **Category**:Clinical Development**Location**:Bangalore, Karnataka, IN**Department - Centralised Monitoring Unit (CMU) - Bangalore**About the department** - The Centralised Monitoring Unit (CMU) - Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers)...

  • Medical Reviewer

    7 months ago


    Bengaluru, Karnataka, India Nexinfra Solutions Full time

    As a Medical Reviewer in Pharmacovigilance, you will play a crucial role in evaluating and assessing the safety of pharmaceutical products. Your primary responsibilities will include reviewing and analyzing adverse event reports, medical literature, and other safety-related information to ensure compliance with regulatory requirements and to contribute to...


  • Bengaluru, Karnataka, India IQVIA Full time

    Job Overview Review structured clinical patient data output without direct access to medical charts to ensure medical plausibility and to determine adherence to protocol and overall completeness and readiness of the supplied patient information for next level of review. Essential Functions - Identify any anomalies in patient reported data that require...

  • Medical Reviewer, Icsr

    7 months ago


    Bengaluru, Karnataka, India ClinChoice Full time

    ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Medical Reviewer on a permanent basis. You will work on projects from our varied client base, ranging from...


  • Bengaluru, India IQVIA Full time

    Job Overview Review structured clinical patient data output without direct access to medical charts to ensure medical plausibility and to determine adherence to protocol and overall completeness and readiness of the supplied patient information for next level of review. Essential Functions - Identify any anomalies in patient reported data that require...


  • Bengaluru, Karnataka, India Lifelancer Full time

    About the RoleWe are seeking a highly skilled Pharmaceutical Medical Review Expert to join our team at Lifelancer. In this role, you will be responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within our drug development portfolio.Key ResponsibilitiesCollaborate closely with study team members,...


  • Bengaluru, India Novo Nordisk Full time

    **Department-** Centralised Monitoring Unit (CMU) - CDS GBS **The Position**: Associate medical reviewer Will be also accountable for: - Develop good therapeutic knowledge and general understanding of diseases and treatments as well as the latest medical developments. - Develop good understanding of relevant protocol and trial specific manuals/plans to...


  • Bengaluru, India Eli Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...


  • Bengaluru, India Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...

  • Medical Data Reviewer

    2 months ago


    Bengaluru, Karnataka, India Stafford Information Technology Pvt. Ltd. Asconis Full time

    **Key Responsibilities**: - Conduct **Risk-Based Monitoring (RBM)** and Centralized Monitoring to identify data trends and potential risks early, addressing them proactively with relevant study teams. - Support **SAE reconciliation, coding review, lab data analysis**, and ensure regulatory compliance across trials. - Utilize tools such as **TIBCO Spotfire...


  • Bengaluru, Karnataka, India IQVIA Full time

    Job Title: Medical Data Review LeadWe are seeking a highly skilled Medical Data Review Lead to join our team at IQVIA. The ideal candidate will have experience in clinical data sciences and possess excellent leadership skills.About the Role:The Medical Data Review Lead will be responsible for overseeing the review of patient-reported data, identifying...

  • Medical Reviewer Ags

    7 months ago


    Bengaluru, India Alcon Full time

    Summary of Position: - Alcon is looking to hire Medical Reviewer who performs_ - Medical Safety activities for assigned Alcon projects or products, supporting the identification and comprehensive assessment of safety signals from all sources (clinical development through post-approval lifecycle management and externally)._ Key Responsibilities: - Perform...


  • Bengaluru, Karnataka, India OMH HealthEdge Holdings Full time

    Omega Healthcare Management Services Private LimitedkarnatakaPosted On - 16 Sep 2024 - Required Experience - 0 - 1 Years Basic SectionNo. Of Openings 8 Grade 1A Designation TRAINEE - MEDICAL REVIEWER Closing Date 30 Sep 2024 - OrganisationalCountry IN State KARNATAKA City BENGALURU Location Bengaluru-II -...


  • Greater Bengaluru Area, India Medilenz Full time

    Medilenz Services is a leading company in Bengaluru that specializes in assisting attorneys, insurance companies, and medical professionals with medical summaries for personal injury, medical malpractice, and mass tort cases. Our proprietary AI-powered software developed in-house, allows us to produce organized and concise summaries. We offer a wide range of...


  • Greater Bengaluru Area, India Medilenz Full time

    Medilenz Services is a leading company in Bengaluru that specializes in assisting attorneys, insurance companies, and medical professionals with medical summaries for personal injury, medical malpractice, and mass tort cases. Our proprietary AI-powered software developed in-house, allows us to produce organized and concise summaries.We offer a wide range of...


  • Bengaluru, Karnataka, India Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Bengaluru, India Daily Rounds Full time

    **What will you be doing here?** - Develop, review and edit academic medical content in the form of MCQs, articles, and notes - Evaluate user feedback and improve the content quality - Keep up to date with developments in the field of medicine and incorporate them into the content **Who are we looking for?** - MBBS graduates (graduated not earlier than 4...


  • Kammanahalli, Bengaluru, Karnataka, India MedVoice Full time

    **Position: Medical Summarization/Abstraction/Records Reviewer** **Immediate Joiners preferred** **Roles and responsibilities**: - **Review medical records to ensure they are complete, accurate, and in compliance with all guidelines and regulations.** This includes verifying the identity of the patient, the dates of service, the diagnoses, the treatments,...