Pv Manager, Safety Reporting
hace 6 meses
Leads multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements.
- Maintains good communications with other functional groups concerning program and company issues. Collaborates with other employees in problem solving and systems improvement.
- Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
- Maintains a basic medical understanding of applicable therapeutic area and disease states. May participate in on-call duties for specific projects and ensures 24-hr coverage for intake of cases from investigative sites.
- Provides plans and accurate forecasts for all projects.
- Serves as resource person to other departmental managers and leads departmental initiatives.
- Prepares and presents proposals.
- Leads staff of expert professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
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Pharmacovigilance Manager
hace 4 semanas
Desde casa, México Thermo Fisher Scientific A tiempo completo**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...
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Safety Reporting Specialist
hace 7 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoReceives, 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...
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Safety Reporting Coordinator
hace 5 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**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...
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Safety Reporting Coordinator
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoJob 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...
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Safety Spec
hace 8 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoPerforms 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...
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Drug Safety Reporting Specialist
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoEssential 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...
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Drug Safety Operations Manager
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoAt 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...
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Safety Reporting Spec
hace 2 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**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...
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Drug Safety Operations Manager
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**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...
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Pharmacovigilance Manager
hace 2 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**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 contribute to world-class research initiatives and work with a...
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Pv Ra Mw Coordinator/ Safety Admin
hace 8 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoPV RA MW Coordinator - Provides support and coordination of review of safety and regulatory publishing documents on receipt. - Assists in reviewing document quality when tracking safety and regulatory publishing data in internal systems and uploading in internal and/or external electronic trial master files. - Ensures redactions for Commercially Confident...
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Safety Spec
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoSummarized 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...
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Safety Spec
hace 5 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**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...
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Sr Safety Reporting Specialist
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoEssential 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...
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Safety Reporting
hace 6 meses
Desde casa, México IQVIA A tiempo completo**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...
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Drug Safety Reporting Senior
hace 8 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoReceives, 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...
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Pharmacovigilance Specialist
hace 6 meses
Desde casa, México Viatris A tiempo completoViatris 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...
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Safety Aggregate Report Specialist
hace 6 meses
Desde casa, México IQVIA A tiempo completoJob 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...
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Sr Programmer Analyst
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**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...
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Trial Programmer Specialist Iii
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**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. -...