Senior Aggregate Reports Specialist

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharmas international awards programs for the last three consecutive years. For more information, visit or follow MMS on ternal title for this role is Senior Safety Writer.Job DescriptionResponsible for the planning, preparation, and submission of high-quality aggregate reports (DSURs, PBRERs, PADERs, etc.) in compliance with global and local regulations and requirementsProvides leadership and direction to report authors and contributorsInteractions cross-functionally both internally and externallyImplements and manages the procedures and tools to ensure high-quality functional deliverables are completedOversees functional specifications of data requirements for aggerate report deliverables from the safety and clinical databasesMaintains strong understanding of global, regional, and local regulatory reporting requirements as they pertain to aggregate reportsPractices excellent internal and external customer serviceGood understanding of MS Word for advanced writing techniquesEnsure documents comply with appropriate ICH and regulatory guidelinesInteract directly and independently with client and their business partnersRequirements2 Years of experience specifically in Drug Safety Aggregate Reports Management and 6 years'' experience in the pharmaceutical industry Masters or PhD in a scientific, medical, or clinical discipline preferredHigh degree of organization and able to manage multiple projects at any given timeStrong attention to detail and committed to excellence in all aspects of their workExcellent oral and written communication and interpersonal skillsProficient in Microsoft Word and Adobe AcrobatExperience in the use of an Electronic Document Management system

Created: 2026-05-02