Pharmacovigilance Senior Specialist
hace 3 semanas
.We are growing, grow with usAre you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective product maintenance.Pharmacovigilance Senior SpecialistYour JobProfessional leadership and provision of pharmaceutical expertise to clients in the field of pharmacovigilance:Management of new pharmacovigilance projects, under the supervision of a Manager.PER Operational Support as:Local Literature Surveillance:Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and relevant information.Screening results of EMA Medical Literature Monitoring (MLM) and L2A.Local literature management through the local PVLit tool.Review and approve changes in literature searches or new strategies and QCs.Periodic monitoring of the timelines and KPIs following the internal SOPs.ICSR Management:MedDRA and ATC coding of Adverse Drug Reactions and Adverse Events.Initial processing of incoming information.If applicable, translation of incoming information into English language including QC.Data entry into PV database (SafetyEasy or client DB) and/or case tracking system e.G. Excel.Initial ICSR assessment, if applicable.Evaluation of the need for expedited reporting to CAs/Partners of a client concerned, including reporting timelines.Preparation of standard reporting forms (i.E.: CIOMS I, Medwatch forms and XML files).Preparation and sending of FU request.Submission of ICSRs to CAs and Partners of a client.Case completion/documentation.Periodic monitoring of the timelines and KPIs following the internal SOPs.Cosmetovigilance:Handling all cosmetic products undesirable effects safety information according to the contract established with the Client.Medical devices:Handling all medical devices undesirable effects safety information according to the contract established with the Client.Medical Information:MI database registration and triage of MI enquiries, AE reports, PQCs, incidents and non-medical enquiries received via email, fax or phone.Management of verbal/written L1 MI enquiries according to approved standard reference documents (e.G. FAQs, SmPC/PIL, SRLs etc) in local language including translations into English, if needed.Responding to the L1 MI enquirer, if applicable.Escalation of L2 MI enquiries to dedicated L2 Support.Submission of AE reports, PQCs and incidents to dedicated destinations.Transfer of L0 non-medical enquiries to dedicated destinations.Preparation and/or maintenance of the FAQ document and Standard Response Letters (SRLs) including annual update in compliance with the most current Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and relevant regulatory documents
-
Pharmacovigilance Senior Specialist
hace 4 semanas
Zaragoza, España Pharmalex Gmbh A tiempo completo.We are growing, grow with us! Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective...
-
Pharmacovigilance Senior Specialist
hace 1 semana
Zaragoza, España PharmaLex GmbH A tiempo completoWe are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective product...
-
Pharmacovigilance Senior Specialist
hace 4 semanas
Zaragoza, España PharmaLex GmbH A tiempo completoWe are growing, grow with us! Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective...
-
Pharmacovigilance Senior Specialist
hace 4 semanas
Zaragoza, España Pharmalex Gmbh A tiempo completoWe are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective product...
-
Pharmacovigilance Specialist
hace 1 semana
Zaragoza, España PharmaLex GmbH A tiempo completoWe are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action...
-
Pharmacovigilance Lead Expert
hace 3 semanas
Zaragoza, Zaragoza, España Pharmalex Gmbh A tiempo completoWe are a dynamic company offering daily new challenges and opportunities. Our job as Pharmacovigilance Lead Expert is ideal for professionals seeking to grow with us. With over 10 years of experience in the pharmaceutical industry, Pharmalex Gmbh is a leading service company specializing in drug approval, market development, and product maintenance.Job...
-
Pharmacovigilance Specialist
hace 4 semanas
Zaragoza, España Pharmalex Gmbh A tiempo completoWe are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action...
-
Pharmacovigilance Senior Specialist
hace 4 semanas
Zaragoza, España Pharmalex Gmbh A tiempo completoWe are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective product...
-
? Solo Quedan 15H Pharmacovigilance Senior Specialist
hace 4 semanas
Zaragoza, España Pharmalex Gmbh A tiempo completo.We are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective...
-
Medical Regulatory Compliance Specialist
hace 3 semanas
Zaragoza, Zaragoza, España Viatris A tiempo completo**About the Role**We are seeking a highly skilled Medical Regulatory Compliance Specialist to join our Pharmacovigilance Department at our Spanish affiliate. As a key member of the team, you will be responsible for maintaining and improving our pharmacovigilance system, ensuring compliance with regulatory requirements and internal standards.**Key...
-
Pharmacovigilance Expert for Global Pharmaceutical Industry
hace 3 semanas
Zaragoza, Zaragoza, España Pharmalex Gmbh A tiempo completoWe are a dynamic and growing company in the pharmaceutical industry. Our mission is to provide expert services to our clients around the world. If you are looking for a challenging and rewarding career, then this may be the opportunity for you.Our company, Pharmalex Gmbh, is a leading service provider for the global pharmaceutical industry. We specialize in...
-
Director Global Pharmacovigilance
hace 2 meses
Zaragoza, España Teva A tiempo completoDirector Global Pharmacovigilance - Safety PhysicianLead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs. Collaborate with other R&D teams to ensure execution of the safety strategy.Contribute to clinical documents,...
-
Pharmacovigilance Specialist
hace 3 semanas
Zaragoza, España Pharmalex Gmbh A tiempo completo.We are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action...
-
Senior Corporate FX Sales Specialist
hace 1 mes
Zaragoza, Zaragoza, España Hamilton Court Fx A tiempo completoAbout UsHamilton Court FX LLP is a leading foreign exchange specialist, serving businesses and financial institutions in the UK and Europe. Our expertise lies in managing currency risks associated with global operations. With offices in London, Milan, and Madrid, we deliver world-class service to help businesses thrive.About the RoleThis position is ideal...
-
Senior Customer Support Specialist
hace 2 meses
Zaragoza, España Ravenpack A tiempo completo.Senior Customer Support Specialist, MadridAbout us: Raven Pack is a leading Alternative Data analytics provider for financial services.Financial professionals rely on Raven Pack for its speed and accuracy in analyzing large amounts of unstructured content.Raven Pack's products allow clients to enhance returns, reduce risk, and increase efficiency by...
-
Senior Logistics Specialist
hace 1 semana
Zaragoza, España Byd Europe A tiempo completo.About the role As a key role for the success of the brand in the fulfillment of customer orders, the Senior Logistics Specialist takes care of the organization of the vehicle logistic flows in Spain, leading the national logistic setup project and the ongoing management of the national logistics, in coordination with the Logistic department and other areas...
-
Senior Quality Specialist
hace 2 semanas
Zaragoza, España Takeda A tiempo completo.About the role : This role will be responsible for Quality activities in relation to Takeda Products commercial activities at Takeda Iberia Local Operating Company (LOC), which includes ensuring that a quality management system is implemented and maintained in accordance with the Guidelines on Good Distribution Practice for medicinal products for human use...
-
Billing Operations Senior Specialist
hace 34 minutos
Zaragoza, España Amadeus A tiempo completo.Job Title Billing Operations Senior Specialist Summary The Services and Implementation (S&I) team within Revenue Management specializes in effort day-related products, handling contract fulfillment and billing activities. The scope of effort day-related products includes consulting, training, product and project implementation and is in close contact with...
-
Senior Logistics Specialist
hace 3 meses
Zaragoza, España Byd Europe A tiempo completo.About the roleAs a key role for the success of the brand in the fulfillment of customer orders, the Senior Logistics Specialist takes care of the organization of the vehicle logistic flows in Spain, leading the national logistic setup project and the ongoing management of the national logistics, in coordination with the Logistic department and other areas...
-
Senior Quality Specialist
hace 2 meses
Zaragoza, España Takeda Pharmaceuticals A tiempo completo.Takeda Pharmaceuticals Senior Quality Specialist Madrid, Spain Apply NowBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in...