Senior Medical Reviewer (Remote) - South Africa

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry-best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on.

Senior Medical Reviewer

Roles and Responsibilities

• Works cross-functionally with team members in other service lines.
• Perform 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.
• Ability to work independently as well as able to integrate with client clinical and safety teams.

Job Requirements

• Medical degree (MD or equivalent), or PharmD.
• Experience with protocol amendments and ICF updates beneficial.
• Experience with aggregate data review for ongoing clinical trials.
• Experience as a clinical scientist who is responsible for timely assessment of the clinical trial data and participation in safety surveillance activities for assigned studies in Phase I-III, including review of medical history, labs, vital signs, medications, and prohibited medications.
• Experience in Oncology required.
• 2 years' experience in technical or medical writing preferred.
• Minimum of 2 years of clinical experience and/or research experience required.
• Excellent knowledge of medical terminology, clinical pharmacology, and regulatory guidelines (ICH, FDA, EMA).
• Excellent scientific writing skills.
• Ability to understand clinical data.
• Proficiency with MS Office applications.
• Strong knowledge of current regulatory practices and domestic and international regulations.

Only candidates from South Africa will be considered for this role.

Should you not receive a response on your application within 14 days, please consider your application unsuccessful.