LAVORO DRUG SAFETY PHYSICIAN PHARMACOVIGILANCE

For safety and clinical projects... the successful candidate will have years of experience in drug safety (icsr, periodic reporting, safety surveillance is a must)...

Provide an independent expert viewpoint on specific safety issues... provide strategic and technical pharmacovigilance advice to global patient safety (gps), and...

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

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

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

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

Who we are looking for purpose the “global pharmacovigilance operations manager, air” supports the global pharmacovigilance team (within r&d) in the execution...

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...

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

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

Who we are looking for purpose the “global pharmacovigilance operations unit head, care” supports the global pharmacovigilance team (within r&d) in the execution...

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

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

What you can expect in a junior regulatory affairs associate role at tp: provide documentation support to the regulatory affairs team for preparing, formatting,...

Collaborates with the occupational health nurse and the site safety professional in medical surveillance management, as needed... prepares employee for medical examination...

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

Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented... possesses proficient therapeutic...

Experience and understanding of drug development in oncology... monitor local and regional pharmacovigilance requirements and maintenance of local legislation repository...