Senior Pharmacovigilance Specialist
Há 3 dias
.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
-
Senior Pharmacovigilance Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Med Communications International Tempo inteiroSenior 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,...
-
Senior Pharmacovigilance Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiroSenior Pharmacovigilance Specialist - Remote Lisboa Senior Pharmacovigilance Specialist - RemoteLisboa Lisboa, Lisboa, Portugal col-wideJob Description:Senior Pharmacovigilance Specialist - RemoteHighlights:Pre and post marketing PV experiencePV Planning in clinical trialsDSUR, PSUR/PBRERRMP writingPOSITION SUMMARYThe Senior Pharmacovigilance Specialist is a...
-
Senior Pharmacovigilance Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Med Communications International Tempo inteiroSenior Pharmacovigilance Specialist - RemotePOSITION 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...
-
Senior Pharmacovigilance Specialist
Há 3 dias
Lisboa, Portugal Med Communications International Tempo inteiroSenior Pharmacovigilance Specialist - Remote Lisboa Senior Pharmacovigilance Specialist - Remote Lisboa Lisbon, Lisbon, Portugal Senior Pharmacovigilance Specialist - Remote Highlights:Pre and post marketing PV experiencePV Planning in clinical trialsRMP writingPOSITION SUMMARYThe Senior Pharmacovigilance Specialist is a professional with scientific,...
-
Senior Pharmacovigilance Specialist
Há 3 dias
Lisboa, Portugal Med Communications International Tempo inteiroSenior Pharmacovigilance Specialist - Remote Lisboa Senior Pharmacovigilance Specialist - RemoteLisboaLisbon, Lisbon, Portugal Senior Pharmacovigilance Specialist - RemoteHighlights:Pre and post marketing PV experiencePV Planning in clinical trialsRMP writingPOSITION SUMMARYThe Senior Pharmacovigilance Specialist is a professional with scientific, clinical,...
-
Pharmacovigilance Specialist
3 semanas atrás
Lisboa, Portugal Labcorp Tempo inteiro**Main Responsibilities**: - Responsible for day-to-day adverse experience case management within the Portugal including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per Client's procedure and country regulations, and health authority submissions of cases in accordance with Global Safety...
-
Pharmacovigilance Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Labcorp Tempo inteiroMain Responsibilities: Responsible for daytoday adverse experience case management within the Portugal including case intake and followup activities in accordance with Global Safety procedures, the review of local literature as per Client's procedure and country regulations, and health authority submissions of cases in accordance with Global Safety...
-
Pharmacovigilance Submission Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Prime Vigilance Ltd Tempo inteiroWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008.We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality...
-
Junior Pharmacovigilance Specialist
2 semanas atrás
Lisboa, Portugal Fortrea - Organic Tempo inteiroAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Medical Writer
2 meses atrás
Lisboa, Portugal PrimeVigilance Tempo inteiroCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
-
Pharmacovigilance Psmf Officer
1 semana atrás
Lisboa, Lisboa, Portugal PrimeVigilance Tempo inteiroCompany DescriptionWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008.We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...
-
Pharmacovigilance Submission Specialist
Há 3 dias
Lisboa, Portugal Prime Vigilance Ltd Tempo inteiroWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality...
-
Pharmacovigilance Project Manager
3 semanas atrás
Lisboa, Portugal PrimeVigilance Tempo inteiroCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
-
Pharmacovigilance Submission Specialist
4 semanas atrás
Lisboa, Portugal PrimeVigilance Tempo inteiro**Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance,...
-
Pharmacovigilance Submission Specialist
4 semanas atrás
Lisboa, Portugal Primevigilance Tempo inteiroWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality...
-
Pharmacovigilance Submission Specialist
3 semanas atrás
Lisboa, Portugal Primevigilance Tempo inteiroWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality...
-
Pharmacovigilance Psmf Officer
3 semanas atrás
Lisboa, Portugal PrimeVigilance Tempo inteiroCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...
-
Pharmacovigilance Submission Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Primevigilance Tempo inteiroWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008.We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality...
-
Pharmacovigilance Submission Specialist
1 semana atrás
Lisboa, Lisboa, Portugal PrimeVigilance Tempo inteiroCompany DescriptionWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008.We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...
-
Lisboa, Portugal Organon Tempo inteiro.Senior Specialist, Quality Assurance Auditor Lisboa Senior Specialist, Quality Assurance AuditorLisboa Lisboa, Lisboa, Portugal Job Description The Position The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides...