Responsible for monitoring the safety profile of newly launched Novartis products in collaboration with the Global Medical Safety Physicians , including authoring complex aggregated safety reports within agreed timeframes and to a high standard of accuracy, and evaluation & quality check of Individual Case Safety Reports (ICSR), in compliance with DS&E business rules, standard operating procedures and global regulatory requirements.
Lead Global DS&E initiatives in collaboration with other Global Line Functions to develop business solutions and meet regulatory requirements.
1. Collaborate with the Medical Safety Physicians and other line functions to monitor the safety profile of newly launched products, by analyzing large data sets, reviewing clinical study protocols, responding to inquiries from Health Authorities, drafting communications to Health Care Professionals, and responding to CPO requests.
2. Lead Global DS&E initiatives to develop business solutions and meet emerging regulatory requirements, by directing cross-functional teams, managing progress, quality and timely completion of deliverables, and reporting progress to DS&E leadership.
3. Author along with Global Medical Safety Physicians, key regulatory periodic safety reports (Periodic Safety Update Reports, US Periodic Reports) for newly launched Novartis products: leading cross-functional expert team and collecting, organizing, analyzing and presenting the data by means of DS&E templates and proce-dures.
4. Lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing).
5. Develop procedures to monitor Central DS&E and CPO compliance to regulatory requirements.
6. Drive the quality review/sampling of ICSRs and literature as part of DS&E quality management system.
7. Review global marketing programs and establish process for AEs collection with global marketing teams as required.
8. Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of pharmacovigilance commitments as required.
9. Proactively collaborate with licensing partners and Clinical Research Organizations to meet joint accountabil-ties.
10. Collaborate with Electronic Data Management team to reconcile Serious Adverse Events between the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database.
11. Co-lead Safety Profiling Teams for newly launched products to ensure that case reports are accurately evalu-ated and databased, and authoring Product Specific Guidelines for assigned products.
12. Lead the preparation of Standard Operating Procedures and Argus processing conventions.
13. Develop and test safety systems/IT applications as business lead/co-lead and support the preparation of rele-vant manuals.
14. Review emerging regulatory guidelines and legislations and identification of impact to DS&E processes.
15. 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.
16. Act as Subject Matter Expert in cross-functional projects and external meetings.
17. Train and mentor new DS&E associates and associates from other line functions.
18. Deputize for Team Leader/Group Head and assist with the recruitment of new staff
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
This position will be filled at a level commensurate with experience. Local candidates preferred
Bachelors degree in Life sciences or Pharmacy required .
Master degree in Life science, PhD, PharmaD or MD desirable
Fluency in English. Knowledge of other languages desirable.
4 to 7 years experience in Drug Development or closely related areas of responsibility, with a minimum of 3 years experience in Drug Safety
Extensive experience in medical writing
Excellent understanding of drug development process, GCP and medical terminology
Strong scientific analytic skills and expertise in large data set analyses
Therapeutic area/disease area expertise
Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions
Strong organizational and project management skills
Ability to lead global and cross-functional work groups
Ability to mentor and coach