Domestic jobs in United Kingdom

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].

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.