Safety Aggregate Report Specialist

**Job Overview** Manage the administrative support for deliverables across the Safety Aggregate Reporting and Analytics (SARA) services, as appropriate. SARA deliverables include safety aggregate reports, literature surveillance, signal detection and benefit risk management services. **Essential Functions*** - Schedule meeting. - Take meeting notes and...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Description** This is a great opportunity for experienced Safety Writers currently working within the life science sector for pharmaceutical companies, biotech companies or Clinical Research Organizations (CROs), to work for a global leading CRO. As the trusted partner of some...

**Job Overview** **Essential Functions** - Process safety data according to applicable regulations, guidelines, SOPs, and project requirements. - Perform pharmacovigilance activities, including collecting and tracking incoming adverse events (AEs) and endpoint information. - Determine initial/update status of incoming events, database entry, coding AEs and...

Receives, prepares, and submits safety reports to applicable parties. Escalates to lead and line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation. Assists in producing metrics and alerts the manager to quality or timeline issues. Participates in project teams and may lead...

Essential Functions Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation. Assists in producing metrics and alerts manager to any quality or timeline issues. Participates on...

Essential Functions Receives, prepares and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis. Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory...

Viatris Healthcare México S. de R.L. de C.V At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted...

**Work Schedule** Other **Environmental Conditions** Office **Sr Programmer Analyst** **Purpose**: **Responsibilities include but are not limited to**: - Collaborates with PV business users to understand the requirements and recommend solutions. - Creates custom and ad-hoc reports from the PV Safety database using built in tools, OBIEE, or SQL. -...

Represents the DSMB/EAC Coordination Team at global and domestic committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and the company's project team, coordinating all logístical aspects and assisting with facilitation. Interfaces with various internal and external parties to implement...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Global Medical Safety lead** Purpose of the Function: - Lead and perform the assessment of medical safety data for assigned products - Develop and execute safety signaling and benefit-risk management strategies - Closely collaborate with stakeholders internally (e.g. Regulatory...

**Job Title: Accounts Receivable Specialist** **Location**: Remote **Department**: Finance / Accounting **Reports to**: VP, Finance **Job Summary**: **Key Responsibilities**: - **Invoice Management**: Prepare, review, and issue customer invoices accurately and in a timely manner, ensuring compliance with company policies and contractual agreements. -...

**Job Title**: Admissions Specialist **Department**: Admissions (Sales & Customer Support) **Reports To**: Admissions Manager **FLSA Status**: Exempt **Approved By**: Chief Commercial Officer **Location**: Remote **Target Hire Date**: ASAP **SUMMARY**: The Admissions' Specialist will report directly to the Admissions Manager to sell all MEA products for B2C...

**Job Overview** We are seeking a dedicated and detail-oriented professional to join our team as a Operations Specialist 1. In this role, you will provide critical phone support to healthcare professionals and patients, handling medical inquiries, adverse events, product quality complaints, and other relevant calls. This position does not involve commercial...

Amentum esta en busqueda de un **Especialista en Seguridad y Ambiente** para unirse a nuestro equipo de operaciones y mantenimiento. Este Especialista sera responsable de proporcionar un nível avanzado de experiência en el apego a la normatividad de ley Mexicana en materia de seguridad industrial, asi como la capacitacion de nuestro equipo en los...

Importante empresa comercializadora y distribuidora de alimentos Solicita **Gerente de Tecnología de la Información** **Perfil requerido**: - Licenciatura/Ingeniería en Sistemas, Electrónica, Informática, Ciencias de la Computación o afín - Experiência mínima de 7 años en puesto similar como Ingeniero en Software, Program Manager o Full Stack...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Essential Functions and Other Job Information**: - Coordinates and reviews safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites....

**Purpose**: **Responsibilities include but are not limited to**: - Collaborates with PV business users to understand the requirements and recommend solutions. - Creates custom and ad-hoc reports from the PV Safety database using built in tools, OBIEE, or SQL. - Develops and validates aggregate safety reports. - Troubleshoots and addresses end user queries...

**Job Overview** **Essential Functions** - Assess Lifecycle Safety data for reportability to relevant authorities, including EudraVigilance, and track reportable cases. - Report to regulatory authorities, ethics committees, institutional review boards, investigators, and oversight groups per legislation, within timelines, and in a format compatible with...

External Job Description **Job Overview** **Key Responsibilities** - Process Safety data as per regulations, guidelines, SOPs, and project requirements. - Perform Pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AE)/endpoint information, database entry, coding AE and Products, writing narratives, and more. - Assess...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Summarized Purpose**: Assists in the management and ongoing evaluation of medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and...