Senior Medical Reviewer (Remote) - South Africa

MMS Holdings Inc.; Bloemfontein; Remote; ZAR 600,000 - 800,000; Full time

Job summary

Join a leading data-focused clinical research organization as a Senior Medical Reviewer. You will be responsible for analyzing clinical trial data, managing safety activities, and preparing regulatory submissions. This role requires strong medical knowledge and experience in Oncology, offering a collaborative environment to advance your career.

Qualifications

• Minimum of 2 years of clinical or research experience.
• Experience in Oncology is required.
• 2 years' experience in technical or medical writing is preferred.

Responsibilities

• Work cross-functionally with team members in other service lines.
• Prepare reports for submission to regulatory agencies.
• Guide regulatory reporting, including NDA annual reports.

Skills

Medical Terminology

Clinical Pharmacology

Scientific Writing

Data Interpretation

Education

Medical Degree (MD or equivalent)

PharmD

Tools

MS Office

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 [social media/platform].

Senior Medical Reviewer

Roles and Responsibilities

1. Work cross-functionally with team members in other service lines.
2. Perform data review by analyzing all data including demographics, efficacy, and safety.
3. Provide expertise as the primary medical reviewer of individual adverse event reports.
4. Guide adverse event coding, retrieval, and analysis activities in drug safety and clinical trials.
5. Aggregate case analysis, safety summaries, and safety signal generation.
6. Lead safety activities on assigned product(s), including interactions with other functional groups in the company.
7. Prepare reports for submission to domestic and international regulatory agencies.
8. Develop strategies for pre- and post-marketing risk management, staying updated on pharmacovigilance methods, trends in published literature, and global regulations.
9. Monitor and analyze cumulative safety information.
10. Manage drug safety crises and develop risk management plans (RMPs).
11. Review safety sections of NDA submissions.
12. Guide regulatory reporting, including ICSRs, NDA annual reports, and PSURs.
13. Coordinate preparation of ad-hoc benefit-risk assessment documents.
14. Plan cumulative safety information analysis, such as signal detection from databases with data mining.
15. Update safety information in company core data sheets and local product labels.
16. Guide regulatory strategies and prepare safety data for authorities and advisory committees.
17. Engage in clinical writing.
18. Work independently and collaboratively with client clinical and safety teams.

Job Requirements

1. Medical degree (MD or equivalent), or PharmD.
2. Experience with protocol amendments and ICF updates is beneficial.
3. Experience with aggregate data review for ongoing clinical trials.
4. Experience as a clinical scientist responsible for timely assessment of clinical trial data and safety surveillance activities for Phase I-III studies, including review of medical history, labs, vital signs, medications, and prohibited medications.
5. Experience in Oncology is required.
6. 2 years' experience in technical or medical writing is preferred.
7. Minimum of 2 years of clinical or research experience.
8. Excellent knowledge of medical terminology, clinical pharmacology, and regulatory guidelines (ICH, FDA, EMA).
9. Strong scientific writing skills.
10. Ability to interpret clinical data.
11. Proficiency with MS Office applications.
12. Strong 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.