LAVORO DRUG SAFETY

Lead proactive safety data reviews... the manager sas will support product safety management teams (smts) and work in close collaboration with other cross-functional...

Experience with translational safety biomarker development/qualification strongly preferred... supports compliance and safety guidelines, including implementation...

The nonclinical submissions writer will prepare and review regulatory submission documents that summarize toxicology, safety pharmacology, drug metabolism, and pharmacokinetics...

Who we are looking for purpose process owner (cross-functional) for developing a wide range of pharmacovigilance documents for the assigned global products within...

Specific responsibilities: provide expert guidance to internal (sgs management, health science network) and external stakeholders (customers, health authorities)...

Thorough understanding of overall process of drug development including model informed drug development (midd) and the overall pharmaceutical r&d process is required...

O execute safety monitoring and assessment as one of core members of j-smt o he or she can be also regarded as study responsible scientist (srs) of assigned local/regional...

Provide an independent expert viewpoint on specific safety issues... provide training /coaching /mentoring and demonstrating global patient safety expertise and...

Forward information to relevant members of the department or study team members; provide internal support to other relevant departments; involved in improvement...

New safety finding) and the associated risk communications... strong working knowledge of the drug development process is required... lead the preparation of regulatory...

For safety and clinical projects... preparing bid-defense response for safety and clinical rfps... the successful candidate will have years of experience in drug...

Requirements   possess an understanding of the regulatory affairs and pharmacovigilance processes for both pre-marketed and post-marketed stages of a product selling...

To test raw materials, intermediates, drug substance, drug products in accordance with quality standard and/or other approved protocols...

Thorough knowledge of drug development process is required preferable to demonstrate leadership in two or more development programs which led to successful clinical...

The integrated environment of our campus gives our people the chance to experience many different aspects of drug development throughout their career...

To oversee signal and risk management activities for chiesi products to ensure patient safety and compliance with global regulatory and quality standards...

Generates documents for orphan drug designation, if applicable...  thorough knowledge of drug development process is required... o establish efficacy and/or safety...

Complete all safety training & observe all safety procedures, both of saint-gobain & those of host companies... por qué te necesitamos? ***while this position is...

Prepare and review cmc documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies...