Pharmacovigilance job @ Novartis
Post : Pharmacovigilance Expert
Provide support to the Medical Safety Department in the single case medical review and associated activities as needed such as Periodic Safety Update Report (PSUR), coordinating the management of large datasets for analysis purposes, responses to Health Authorities, within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating procedures and global and local regulatory requirements.
1.Performs single case medical review in the safety database or on line listings Of Oncology marketed products.
2.Author or co-authors the medical sections of PSURs including literature review and analysis of known and potential risks defined in the RMP.
3.Assists in the preparation of other safety documents, as needed/required, including Annual Safety Update Reports (ASR) , DSURs, Core Data Sheets (CDS) and IBs.
1.Quality of work delivered (attention to details, thoroughness, medical sound judgment, writing)
2.Writing of precise queries allowing for quality data in response
3.Timeliness of deliverables according to established directives
4.Compliance with Internal and external regulations and procedures
5.Level of independence.
Candidate Profile :
Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/ or Medical Degree (MBBS or MD) Good knowledge/fluency in English. Knowledge of other languages desirable.