Novartis is a global healthcare leader and has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We appreciate and welcome your interest in joining our team of associates from more than 150 nationalities who currently share our mission to care and to cure.
Job Title – Principal Pharmacovigilance Scientist
Job ID – 196980BR
Location – Hyderabad
PhD, Pharm-D or MD desirable Bachelors or Pharmacy as a minimum requirement 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.
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 procedures.
4. Lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing).
5. Drive the quality review/sampling of ICSRs and literature as part of DS&E quality management system.
6. Review global marketing programs and establish process for AEs collection with global marketing teams as required.