Safety Reporting Specialist

Job Description **Summarized Purpose**: Provides administrative safety support to the Pharmacovigilance department. Specifically in relation to submissions, tracking and subsequent filing and archiving or expedited and periodic safety reports. This includes other general administration tasks such as filing, photocopying, typing and performing reconciliation...

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...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description**: At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with...

**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 Join Thermo Fisher Scientific Inc. as a Pharmacovigilance Manager and be at the forefront of ensuring patient safety in an outstandingly collaborative and innovative environment. This is an outstanding opportunity to support to exceptional research initiatives and work with a team...

Job Overview Serve as principal owner of the SARA deliverable and have responsiblility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions - Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. - Lead, author...

**Job Overview** Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. **Essential Functions** - Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. - Lead,...

**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...

**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...

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. - Identifies and resolves any quality or timeline issues and keeps the Manager informed of progress. - Exercises independent judgment to troubleshoot, resolves...

**Be part of our dynamic community and make a real impact on our clients' success. Assistantly offers some of the best benefits and perks in the industry.** **Unicorn Role Overview**:Do you have a talent for promoting safety and ensuring smooth operations? As a Safety Administrator, you'll be the driving force behind our client's safety programs, ensuring...

**Purpose** The Quality Manager, Lifecycle Safety, is responsible for quality, compliance and deviation management across global Lifecycle Safety functions including ICSR case processing, Regulatory reporting, Medical Information, endpoint adjudication and aggregate reporting. The Quality Manager will partner with Lifecycle Safety functional specialists...

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...

**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. -...

Performs day-to-day Pharmacovigilance (PV) activities within a highly regulated environment and driven by strict timelines. PV activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. - Coordinates and performs PV activities such as data entry, coding and assessment of adverse...

**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...

Summarized Purpose: Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance activities...

**Work Schedule** Other **Environmental Conditions** Office Summarized Purpose: Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety...

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...