Pharmacovigilance Specialist
hace 6 meses
**Job Overview**
Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.
**Essential Functions**
- Pharmacovigilance processes applicable to RSU.
- Submission of safety reports (periodic and expedited)
- Submission of SAE/SUSAR to RA on time for the applicable studies according to regulatory timelines.
- Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
- May also include maintenance activities.
**Qualifications**
- Bachelor's Degree Life sciences or a related field.
- 1 - 2 years of pharmacovigilance experience in clinical studies.
- Fluent Conversational English.
-
Manager, Pharmacovigilance
hace 7 meses
Tlahuac, México ICON A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...
-
Safety Specialist
hace 6 meses
Tlahuac, 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...
-
Especialista de Farmacovigilancia
hace 6 meses
Tlahuac, México Johnson & Johnson A tiempo completoAt **Johnson & Johnson **, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than...
-
Operations Specialist
hace 6 meses
Tlahuac, México Novasyte A tiempo completoJob Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team...
-
Healthcare Compliance Sr Specialist
hace 6 meses
Tlahuac, México Johnson & Johnson A tiempo completoDiversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest...
-
Senior Specialist, Quality Assurance Auditor
hace 6 meses
Tlahuac, México Organon A tiempo completo**Description of The Position** The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and...