Retrospective review of study documents to ensure adherence to required SOPs and regulatory requirements.
Ensuring quality by reviewing all study related documents like Regulatory binder, Raw data binders, Case Report Form binders, Study close out report, Sample Case record form, Study updates, screening examination
Monitoring of SAE and AE management and reporting to all applicable bodies (Regulatory, Ethics committee, Sponsor and PVPI team.)
Ensuring compliance of standard operating procedures, regulatory guidelines and all applicable laws
Review of SDTM & Clinic tables data with the source document.
Quality Control of study activities such as IP dosing, sample collection, sample separation, sample segregation, verification and sample transfer for all clinical studies
Plan and conduct general in-house audits of facility areas like pharmacy, screening, clinic ward, ICU
Ensure that the processes needed for Quality management system are established, implemented and maintained.
To verify the calibration and verification of instruments/equipment.
To coordinate with the user department and medical writing department for clinical study reports.
Quality Review of protocol & Informed consent forms by referring the available literature for the drug molecule.
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.
Teamlease does not charge any kind of payment for a job.