Medical Reviewer

3 days ago

Melbourne, Australia ProductLife Group Full time

ProductLife Group is looking for Medical Reviewers, responsible for reviewing and evaluating adverse event (AE) reports, ensuring accurate medical assessments, compliance with regulatory requirements, and the overall quality of safety data. The role requires close collaboration with pharmacovigilance teams, regulatory authorities, and healthcare professionals to ensure patient safety and product efficacy in **Oncology, Neurosciences & Rare disease areas**:
**Qualification & Experience Required**:

- **Education**: MBBS/MD.
- **Experience**: Minimum of **Oncology, Neurosciences & Rare diseases**.

**Key Responsibilities**:

- **Medical Review**: Perform in-depth medical assessments of Individual Case Safety Reports (ICSRs) from clinical trials, post-marketing surveillance, and spontaneous reporting systems.
- **Case Processing**: Review and verify the accuracy of AE case processing, including medical coding (MedDRA), narrative writing, and consistency in data entry.
- **Regulatory Compliance**: Ensure all reports comply with local and global regulatory guidelines, such as ICH, EMA, FDA, and GVP.
- **Signal Detection & Risk Management**: Contribute to signal detection, benefit-risk evaluations, and risk management plans (RMPs) by analyzing AE data trends.
- **Safety Reporting**: Collaborate on the preparation and review of periodic safety reports, such as PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), and other regulatory safety documents.
- **Cross-functional Collaboration**: Work closely with cross-functional teams, including safety physicians, data management, regulatory affairs, and clinical teams, to ensure high-quality pharmacovigilance deliverables.
- **Audits & Inspections**: Participate in internal audits and regulatory inspections by ensuring accurate documentation and compliance with pharmacovigilance processes.
- **Continuous Improvement**: Stay updated on pharmacovigilance and medical guidelines, participating in relevant training programs to maintain best practices.

**Skills**:

- Strong understanding of pharmacovigilance regulations and guidelines (ICH, GVP).
- Proficiency with pharmacovigilance databases (Argus, ArisG, etc.).
- Excellent attention to detail and medical writing skills.
- Excellent communication and team collaboration abilities.

Application Question(s):

- What is therapeutic area of expertise ?
- Do you have any experience in rare disease ?
- Do you have MBBS or MD Degree?

  • Medical Case Manager Medical Review

    4 weeks ago

    Melbourne, Victoria, Australia Department of Transport and Planning Full time

    Join to apply for the Medical Case Manager Medical Review role at Department of Transport and Planning2 days ago Be among the first 25 applicantsJoin to apply for the Medical Case Manager Medical Review role at Department of Transport and PlanningTitle: Medical Case Manager Medical ReviewRequisition ID: 7756Work Type: Ongoing Full TimeFixed Term Period: Not...

  • Medical Case Manager Medical Review

    4 weeks ago

    Melbourne, Victoria, Australia Department of Transport and Planning Full time

    Join to apply for the Medical Case Manager Medical Review role at Department of Transport and Planning3 days ago Be among the first 25 applicantsJoin to apply for the Medical Case Manager Medical Review role at Department of Transport and PlanningGet AI-powered advice on this job and more exclusive features.About UsThe Department of Transport and Planning...

  • Medical Receptionist

    2 weeks ago

    Melbourne, Victoria, Australia Q1 Medical Full time

    **Position Description - General Practice Receptionist****Reports to**: Practice Manager**Purpose of position**To warmly welcome and engage with patients who enter the clinic. Also to organise appointments, maintain records and perform medical & other tasks in order to ensure smooth and efficient functioning of the practice and provide an exceptional...

  • Clinical Review Nurse

    2 weeks ago

    Melbourne, Victoria, Australia A-Line Staffing Solutions Full time

    Overview A-Line Staffing Solutions is hiring a remote clinical review RN with a large managed care organization working on the west coast (CA, OR, or WA).Job Title: Utilization Review RNPay: $40 per hour Job Type: Full-time Shift Options Training going from 6 AM-3 PM PST Mon-Fri (2 weeks, NO TIME OFF)10-7 PST Tuesday-Saturday10-7 PST Sunday-Thursday8-5 PST...

  • Medical Practice Manager

    2 weeks ago

    Melbourne, Australia Middle Camberwell Medical Centre Full time

    **Job Summary**: Familiarity with Medical Director clinical software Current First Aid and CPR certification Living in Australia **The Position**: Practice Manager full time **Practice**: Middle Camberwell Medical Centre (MCMC) - Camberwell, Victoria **About our Clinic and People**: MCMC is an AGPAL accredited family-owned private billing practice **Our...

  • Clinical Review Nurse

    3 weeks ago

    Melbourne, Victoria, Australia A-Line Staffing Solutions Full time

    OverviewA-Line Staffing Solutions is hiring a remote clinical review RN with a large managed care organization working on the west coast (CA, OR, or WA).Job Title: Utilization Review RNPay: $40 per hourJob Type: Full-timeShift OptionsTraining going from 6AM-3PM PST Mon-Fri (2 weeks, NO TIME OFF)10-7 PST Tuesday-Saturday10-7 PST Sunday-Thursday8-5 PST...

  • Independent Academic Reviewer

    2 weeks ago

    Melbourne, Victoria, Australia beBeeMedicalResearch Full time $80,000 - $120,000

    ">Freelance Medical Research Expert">">We are seeking experienced professionals to collaborate with us as freelance peer reviewers in Gastroenterology and Hepatology.">This is a unique opportunity for researchers, retired researchers, and former researchers to contribute their expertise to the scientific community.">Key Responsibilities:">">Evaluate...

  • Review Support Officer

    2 weeks ago

    Melbourne, Victoria, Australia Department of Justice and Community Safety, Victoria Full time

    Utilise your Administrative expertise to provide support and advice to the Integrity and Reviews branchAn Ongoing, Full-Time opportunity to work with a high-performing and passionate team in the Victorian Public ServiceAbout This RoleUtilise your Administrative expertise to provide support and advice to the Integrity and Reviews branchAn Ongoing, Full-Time...

  • Review Support Officer

    2 weeks ago

    Melbourne, Victoria, Australia Department of Justice and Community Safety, Victoria Full time

    Utilise your Administrative expertise to provide support and advice to the Integrity and Reviews branchAn Ongoing, Full-Time opportunity to work with a high-performing and passionate team in the Victorian Public ServiceAbout This RoleUtilise your Administrative expertise to provide support and advice to the Integrity and Reviews branchAn Ongoing, Full-Time...

  • Medical Receptionist

    2 weeks ago

    Melbourne, Victoria, Australia Vic Medical And Allied Health Pty Ltd Full time

    We are a leading healthcare services provider operating out of Melbourne's northern and eastern growth corridor.Our professional staff deliver a wide variety of clinical, community health and wellbeing services.We are searching for enthusiastic Medical Receptionists to join our team in our clinics located in Hawthorn/ Keysborough / Epping /Pakenham and...