and accuracy of all case reports received from any source.Functional relationship with Global DrugSafety and Pharmacovigilance and local departments to ensure regulatory reporting compliance. Main Activities:Processing all individual/periodic case reports...
aware of the legal, ethical and corporate rules governing the activities under own responsibility, and acts in compliance with them; - Proactively interacts with the DrugSafety in reporting suspected adverse reactions.
Requirements:
• Degree...
and activities:
Main Responsibilities:
• Ensuring appropriate quality and accuracy of all case reports received from any source.
• Functional relationship with Global DrugSafety and Pharmacovigilance and local departments to ensure regulatory reporting...
pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials.
Position Summary
This leader will lead...
Some positions require Federal Motor Carrier Safety Administration (FMCSA) registration/clearance as well as ongoing alcohol and drug testing.
Location: Oro Grande, CA, US, 92368
Job Type: Salaried
Nearest Major Market: Riverside
Nearest Secondary...
with ethical standards, professional ethics and legal regulations; - Proactively interacts with the DrugSafety Department in reporting suspected adverse reactions; - Implements the approval procedures of promotional materials and communications...
to ensure the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety. This position also participates in the strategic planning and execution of critical development programs for a variety of clients...
represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development...
and ensure compliance with safety and regulatory standards.
• Oversee the execution of clinical trials, including safety reviews, data analyses, and decision-making for dose escalation and expansion cohorts.
• Ensure the preparation of high-quality regulatory...
represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development...
a strong background in both small and large molecule technologies.
2. Extensive knowledge and experience with late-stage clinical and commercial biologics drug substance and drug product manufacturing programs, in both small and large molecule.
3. Proven...
represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development...
training takes place for direct reports in areas such as safety and environmental health.
SAFETY:
• Set standards for safe behavior. Recognize and reward safe behavior in others.
• Ensure that direct reports employ safe practices. Enforce safety policies...
and Global Teams in local Clinical Development activities and in Global and International Med Affairs activitiesOversee together with Patient Safety local clinical trial adverse event reporting as well as clinical input and oversight into adherence to GCP...
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well:being of people...
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