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 them one of the most rewarding employers in their field.
Post: Pharmacovigilance Team Manager.
1. Maintain assignments for Periodic Safety Update Reports (PSURs), PSUR Addendum Reports (ARs), Bridging Documents (BDs) and US Periodic Reports (USPRs) within DS&E PVO Hydera-bad.
2. Authoring of Periodic Safety Update Reports (PSURs), PSUR Addendum Reports (ARs), Bridg-ing Documents (BDs) and US Periodic Reports (USPRs).
3. Perform quality control (QC) of PSURs as per SOPs/guidelines and provide feedback to au-thors to ensure quality standards are maintained across the organization.
4. Correction of PSUR comments and individual case reports, as needed.
5. Advise Hyderabad DS&E associates on regulatory requirements and other safety reports related questions.
6. Ensure full compliance of all periodic reports written in SP&R Hyderabad with DS&E SOP timelines and in case of a delay investigate root cause and implement corrective action. Be aware of the global compliance reporting rate.
7. Support writing of PSUR/AR/BD templates and SOPs and update as necessary according to emerging regulatory requirements. 8. Be aware of the global compliance reporting rate.
9. Provide training to authors within Hyderabad organization.
10. Participate in cross-functional teams as needed.
11. Provide support as required for regulatory authority inspections and audits.
12. Deputize for the global PSUR coordinator within DS&E. Manage daily operation and complete the task as per require TAT.
Master Degree English Relavant Experience in Slotted Dev & Med.
Job ID: 186058BR
Business Unit: Global Develop NPH
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D