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
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