Astra Zeneca Work Values

Daily Duties at Astra Zeneca:

? The responsibility involves preparation of the Global clinical and non-clinical or spontaneous serious case lists for a particular week and present these cases in the meeting with discussions involved. ? Practical experience with compliance with FDA and ICH Regulations and standard operative procedures for Worldwide Adverse Event Reporting. ? Expertise in leading Teams and studies within the cardiovascular clinical operations group. ? Knowledge of the entire drug development process including study plan development, study areas and the execution of entire clinical study chain. ? Quality controlled the work documents of other employees in the team before submissions to regulatory affairs. ? Routine review of adverse events globally for the AZ Products. ? Experience with phase 4 and post marketed trials. ? Good experience with review of study protocols, Investigator Brochure and participated in annual IND reports. ? Proficiency and working knowledge of FDA and ICH Guidelines. ? Experience with processing SAE’S. Experience with writing narratives, editing cases in the databases, Scanning cases for a photocopy and submission of reports, attending the safety meetings. ? Experience with creation of case files from SAE documents attached to case. Tracking cases in daily workflow and with CRO’S to ensure timely review and submission. ? Interactions with prescribes at local level ? Interaction with members of the clinical team at global level. ? Safety data evaluations. ? Good experience with routing of expedited safety reports to clinical and regulatory groups for electronic sign offs. ? Attended the cross-functional team meetings to discuss various issues and submit the list of cases to operational groups for timely PSUR Comments. ? Involved in hypercholesterolemia and hyperlipidemia studies. [Phases 1, 2, 3] ? Worked with other team members in completing the prioritized reports or documents. Regular use of Business Objects, Clintrace and MEDRA to generate reports and perform various search queries. Completed the Certification training in GEL-Review [Global Electronic Library] ? Experience with Oracle AERS, SOP writing and review. ? Worked with the post-marketed drug CRESTOR [Used in the therapy of hypercholesterolemia and other hyperlipidemias]. Participated in the preparation of the PSUR [Periodic Status Update Report].

What they like about Astra Zeneca:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

Director of clinical research, Manager of drug safety, Senior clinical research associate, Regional clinical research associate

Skills

P&L responsibilities, Presentation, Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Technology Solutions, Sales Support, Software Implementation, Requirements Analysis & Specification, Leadership , Excellent design , planning and implementation

These are some of the questions we asked our climbers about their experiences with Astra Zeneca: