Senior Pharmacovigilance Specialist

Há 3 dias


Lisboa, Portugal Med Communications International Tempo inteiro

.Senior Pharmacovigilance Specialist - Remote Lisboa Senior Pharmacovigilance Specialist - RemoteLisboa Lisbon, Lisbon, Portugal Senior Pharmacovigilance Specialist - Remote Highlights: Pre and post marketing PV experience PV Planning in clinical trialsRMP 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,- 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(s): Demonstrate proficiency in the use of the safety database and associated safety system(s). Demonstrate proficiency with MedDRA and WHODrug coding Integrate scientific expertise with knowledge of safety database functions to ensure accurate and comprehensive case data entry and identification of- up requirements for all case types, received from multiple sources, such as spontaneous, clinical trial,- authorization safety studies, scientific literature, etc Monitors the Client email Inbox, performs review, analysis, triage and filing of safety information within established timeframes Processes safety information in relevant computerized system (e. g. PV database): data entry, MedDRA and WHODrug coding, case narrative writing, quality control, reconciliation, as per client specific requirements Ensures quality, compliance and consistency of all steps of case processing activities (case management) Cooperates with the Medical Reviewer to collect all required information and determine AE medical assessment Complete medical literature search activities for pharmacovigilance purposes Complete social media search activities for Client products for pharmacovigilance purposes, if needed Contributes and/or assists in preparation (writing, compilation) of expedited and periodic safety reports (including Suspected Unexpected Serious Adverse Reactions (SUSAR), DSUR, Line listings, IND safety reports) Assistance/writing of aggregate safety reports (PSURs/PBRERs, ADCOs, PADERs etc



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