Senior Medical Reviewer (Remote) - South Africa

MMS Holdings Inc.; KwaZulu-Natal; Remote; ZAR 50 000 - 100 000; Full time

Job summary

Join a forward-thinking clinical research organization where your contributions matter. As a Senior Medical Reviewer, you'll play a vital role in analyzing clinical data and ensuring safety in trials. This position offers the chance to lead safety activities, prepare regulatory submissions, and develop risk management strategies. With a commitment to fostering a collaborative and inclusive environment, this organization is dedicated to shaping the future of clinical research. If you have a passion for oncology and a strong background in medical writing, this is the opportunity for you!

Qualifications

• Medical degree or PharmD required for the role.
• Experience in Oncology and clinical data assessment is essential.

Responsibilities

• Analyze data and provide expertise as a medical reviewer.
• Prepare reports for regulatory submissions and lead safety activities.

Skills

Oncology expertise

Clinical data assessment

Medical writing

Regulatory guidelines knowledge

Data analysis

Education

Medical degree (MD or equivalent)

PharmD

Tools

MS Office applications

Job description

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-leading 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 maintains an industry-leading customer satisfaction rating and fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team 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 [insert relevant platform].

Senior Medical Reviewer

Roles and Responsibilities

• Work cross-functionally with team members in other service lines.
• Perform data review by analyzing all data including demographics, efficacy, and safety.
• Provide expertise as the primary medical reviewer of individual adverse event reports.
• Guide adverse event coding, retrieval, and analysis activities in drug safety and clinical trials.
• Conduct case aggregation, safety summaries, and safety signal generation.
• Lead safety activities on assigned product(s), including interactions with other functional groups within the company.
• Prepare reports for submission to domestic and international regulatory agencies.
• Develop strategies for pre- and post-marketing risk management, staying updated on pharmacovigilance methods, trends in literature, and global regulations.
• Monitor and analyze cumulative safety information.
• Manage drug safety crises and develop risk management plans (RMPs).
• Review safety sections of NDA submissions.
• Oversee regulatory reporting, including ICSRs, NDA annual reports, and PSURs.
• Coordinate the preparation of ad-hoc benefit-risk assessments.
• Plan cumulative safety information analysis, such as signal detection from databases.
• Update safety information in company core data sheets and local product labels.
• Guide regulatory strategy and prepare safety data for authorities and advisory committees.
• Contribute to clinical writing tasks.
• Work independently and collaboratively with client clinical and safety teams.

Job Requirements

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

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

If you do not receive a response within 14 days, please consider your application unsuccessful.