Senior Pharmacovigilance Specialist (Argus)

Job description

Senior Pharmacovigilance Specialist - Remote Highlights: - Pre and post marketing PV experience - PV Planning in clinical trials - DSUR,PSUR/PBRER - RMP writing POSITION SUMMARY: The Senior Pharmacovigilance Specialist is a professional with scientific, clinical, and therapeutic area expertise responsible for case management activities, expedited/non-expedited reporting activities, periodic reporting activities, risk management, signal detection and surveillance, ad-hoc reporting, and participation in safety meetings for drugs, biologics, devices, vaccines, cosmetics, and/or animal products, according to applicable Standard Operating Procedures (SOP), project specific supporting documents, ICH Good Clinical Practice (ICH GCP), Good Pharmacovigilance Practice (GVP) and all other applicable regulations and standards. Senior Pharmacovigilance Specialists tasks depend on the process/project/role assigned. ESSENTIAL FUNCTIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions. Essential Functions Statement...