Medical Reviewer

3 days ago

Cape Town, South Africa MMS Full time

We're looking for an experienced Clinical/ Medical Reviewer who will report into our Director of Drug Safety and Pharmacovigilance. This role is fulltime for at least one year, with extension possible.

**Roles & Responsibilities**
- Works cross-functionally with team members in clinical data management
- Performs data review by reviewing all data including demographics, efficacy and safety
- Provide significant expertise as primary medical reviewer of individual adverse event reports
- Guide adverse event coding, retrieval and analysis activities in drug safety and clinical trials
- Aggregate case analysis, safety summaries and safety signal generation
- Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company
- Prepare reports for submission to domestic and international regulatory agencies
- Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations
- Responsible for strategies in monitoring and analysis of cumulative safety information
- Responsible for drug safety crisis management and risk management plans (RMPs)
- Guide reviews of safety sections of NDA submissions
- Guide regulatory reporting including individual case safety reports (ICSRs), NDA annual report summary statements, and periodic safety update reports (PSURs)
- Guide and coordinate preparation of ad-hoc benefit-risk assessment documents
- Plan cumulative safety information analysis such as signal detection from company or public databases with data mining
- Guide safety updates of company core data sheet and local product labels
- Guide regulatory strategy and preparation of data related safety to regulatory authorities and advisory committees
- Responsible for clinical writing
- Interact with client matters related to changes and information required
**Job Requirements**
- Medical degree (MBChB), or BPharm required
- Experience in Oncology required
- 1+ year experience in technical or medical writing preferred
- 1+ year of clinical experience and/ or research experience required
- Excellent scientific writing skills
- Ability to understand clinical data
Good communication skills
- Strong knowledge of current regulatory practices and domestic and international regulation

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