Novartis hiring "A"

Medical Safety Writer

Novartis Healthcare Pvt. Ltd.

5 - 7 yrs

Hyderabad / Secunderabad

Job Description

Lead global cross-functional teams responsible for writing periodic safety reports within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating procedures and global regulatory requirements. Responsible for supporting the Global Medical Safety Physicians in the monitoring of the safety profile of newly launched Novartis products. 1. Lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Cli n- ical, Marketing). 2. Author along with Global Medical Safety Physicians, regulatory periodic safety reports (Period- ic Safety Update Reports, US Periodic Reports) for newly launched Novartis products: collect- ing, organizing, analyzing, presenting the data and drafting safety medical evaluations by means of DS&E templates and procedures. 3. Collaborate with the Medical Safety Physicians and other line functions to monitor the safety profile of newly launched products emerging from aggregate reporting or large data set anal- yses. 4. Review emerging regulatory guidelines and legislations and identification of impact to DS&E processes. 5. Drive and Lead DS&E projects to develop new PSUR processes in alignment with international regulations. 6. Lead the development and maintenance of safety documents templates and Standard Operat- ing Procedures pertaining safety aggregate reports. 7. Lead sessions during Health Authorities inspections and audits as Subject Matter Expert, and lead the development and implementation of Corrective and Preventative Actions (CAPA) to address safety findings. 8. Review global marketing programs and establish process for AEs collection with global mar- keting teams. 9. Review Risk Management Plans in close coordination with Pharmacovigilance Compliance and Global Medical Safety groups and assess the operational feasibility and implications of phar- macovigilance commitments. 10. Contribute to Safety Profiling Teams to newly launched products to ensure that case reports are accurately evaluated and databased, and have reliable and exploitable data sets when preparing aggregate reports. 11. Proactively collaborate with licensing partners and Clinical Research Organizations to meet joint accountabilities. 12. Act as Subject Matter Expert in cross-functional projects and external meetings. 13. Train and mentor new DS&E associates and associates from other line functions on medical safety writing & periodic reporting matters. 14. Deputize for Team Leader/ Group Head and assist with the recruitment of new staff.

Key Performance Indicator(s) (HR Core IT9102 ST9003) 

Company Profile:

Novartis Healthcare Pvt. Ltd.

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.  

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