LAVORO DRUG SAFETY PHYSICIAN GLOBAL

We are recognized as the global benchmark for sustainability, quality and integrity... job description the director global scientific & technical excellence is primarily...

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

Lead proactive safety data reviews... required skills: working knowledge of medical concepts and familiarity with safety activities in drug development and post...

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...

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

It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery...

Electronic safety document management systems, front-end solutions, robotic process automation)... support change control management when global pharmacovigilance...

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

Provides input to global ct and compound development team (cdt)... ・responsibilities in global study ・study planning o reviews study plan and design [i...

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...

Responsibilities in global study •reviews study plan and design [i... provides input to global clinical team (ct) and compound development team (cdt)...

Safeguard patient safety... experience in support of global regulatory submissions for medical devices, biologics or drugs is desirable (including pma/bla/nda and/or...

New safety finding) and the associated risk communications... collaborate with global cross-functional teams and the global regulatory affairs (gra) function/teams...

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

Study design, patient selection and precision approaches, endpoints (including novel endpoints), safety evaluation, dose, pharmacology, and pharmacodynamic biomarkers...

Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs... prepare and review cmc documentation...

Main responsibilities the person will: execute activities related to the procurement and production of drug substance, drug product, and patient kits carried out...