AstraZeneca is Hiring for Manager -regulatory Affairs & Patient Safety and has issued notification to accept Applications.AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process..Application form link provided at the end of post. Eligibility for the Manager -regulatory Affairs & Patient Safety as follows.
Vacancy summary details :
- Company Name: AstraZeneca
- Location : Bangalore
- Post Name: Â Manager -regulatory Affairs & Patient Safety
- Qualification: Medical graduation/ M.Pharm / M.Sc/ PhD
- Experience: 00 Years
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Closing date for online Application : Apply as soon as possible
- Date of examination: NA
- Time and Venue :NA
- Mode of application : online
- Selection Process: Shortlisted candidates may called for selection process (Â Personal interview , Group discussion , etc…,)
Job Description/Skills Required:Â
- Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch
- Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals / permissions
- Monitor and understand the impact of external changes in the regulatory environment that will impact on the assigned products
- Communicate the impact of changes to key stakeholders.
- Monitor the global pipelines of competing pharmaceutical companies
- Analyse gathered information for its impact on AstraZeneca proposed pipelines
- Provide scenario with options and a risk – benefit analysis for AstraZeneca going forward
- Monitor status of product licenses and communicate changes to licenses status promptly
- Project manage changes in product licenses and coordinate with other changes, planned and in progress
- Provide Leadership and direction within project teams
- Enhance positive attitudes and mindset. Demonstrate confidence and conviction.
- Challenge status quo for continuous improvement.
- Recording and processing of SAEs from clinical studies, and of adverse events from spontaneous and solicited sources, including pregnancy, overdose, lack of effect, medication errors, product quality complaint or health authority reports according to Global and Local standard operating procedures
- Ensures local language medical and scientific literature is periodically reviewed to identify possible case reports, and forwards all the above in a timely manner to the appropriate Data Entry Site (DES) (Patient Safety Standards SOP)
- Ensures that local tracking is maintained in JASPER and captures the date that case reports were received at AstraZeneca, date forwarded to DES, attempts made to obtain follow-up information (applicable to post-marketed reports only), date follow-up data is received, and date submitted to regulatory authorities, where applicable. Where a case has been posted in JASPER but does not qualify for local regulatory submission ensures that the reason is documented. (Patient Safety Standards SOP)
- Providing safety reporting training (and for product quality complaints as required) to other company employees
- Ensures AstraZeneca Pharma India Ltd. personnel are trained on an ongoing basis, on safety reporting requirements and timely reporting to Patient Safety and that any change to Patient Safety procedures is communicated to relevant personnel through appropriate training/coaching.
- Periodic review of Prescribing Information
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
Click here for notification and Apply

