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Medical Reviewer

3 weeks 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?