Senior Medical Reviewer (Remote) - South Africa

MMS Holdings Inc.; Unterhaching; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

MMS Holdings Inc. is seeking a Senior Medical Reviewer to join their innovative team. The role involves conducting data reviews, preparing regulatory submissions, and leading safety activities for clinical trials. Candidates should possess a medical degree and have experience in Oncology, with strong scientific writing skills. This position offers the opportunity to contribute significantly to the future of clinical research within a supportive and collaborative environment.

Qualifikationen

• Minimum of 2 years' clinical or research experience.
• Experience in Oncology is required.
• Strong scientific writing skills.

Aufgaben

• Perform data review by examining demographics, efficacy, and safety data.
• Prepare reports for submission to regulatory agencies.
• Lead safety activities on assigned products.

Kenntnisse

Medical terminology

Clinical pharmacology

Scientific writing

Data interpretation

Ausbildung

Medical degree (MD or equivalent)

PharmD

Tools

MS Office

Jobbeschreibung

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 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 our website.

Senior Medical Reviewer

Roles and Responsibilities

• Work cross-functionally with team members in other service lines.
• Perform data review by examining demographics, efficacy, and safety data.
• 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 aggregate case analysis, safety summaries, and safety signal generation.
• Lead safety activities on assigned products, 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, and regulations.
• Monitor and analyze cumulative safety information.
• Manage drug safety crisis and risk management plans (RMPs).
• Review safety sections of NDA submissions.
• Oversee regulatory reporting, including ICSRs, NDA annual reports, and PSURs.
• Coordinate preparation of benefit-risk assessment documents.
• Plan cumulative safety data analysis, including signal detection using data mining techniques.
• Update safety information in company core data sheets and local product labels.
• Guide regulatory strategies 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 trials, including review of medical history, labs, vital signs, and medications.
• Experience in Oncology is required.
• At least 2 years' experience in medical or technical writing preferred.
• Minimum of 2 years' clinical or research experience.
• Excellent knowledge of medical terminology, clinical pharmacology, and regulatory guidelines (ICH, FDA, EMA).
• Strong scientific writing skills.
• Ability to interpret clinical data effectively.
• Proficiency in MS Office applications.
• Solid 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.

Create a job alert for this search

Location: Durban, Free State, South Africa