Safety Reporting Spec

**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 tasks. Involved...

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...

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...

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...

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...

Summarized Purpose: Provides administrative safety support to the safety reporting team and Pharmacovigilance department. Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department’s projects. Assists with allocation of work tasks to safety reporting team...

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...

**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...

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...

**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 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...

The Scheduler plays a vital role in organizing and managing the schedules of motorcycle training sessions, instructors, participants, and resources to ensure that the training programs run smoothly and efficiently. **KEY RESPONSIBILITIES**: **Training Session Scheduling**: - Coordinate and schedule motorcycle safety training sessions, ensuring that they...

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 the resources needed to achieve individual career goals while taking science a step beyond through...

**Work Schedule** Other **Environmental Conditions** Office 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 the resources needed to achieve...

**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...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - Prepares, reviews and coordinates local regulatory submissions and strategies (MoH, EC, approvals, viral safety dossiers, import license) in alignment with global submission strategy. - Technical expertise and coordination oversight for projects in collaboration with relevant...