Senior Pharmacovigilance Specialist
hace 6 días
**About Tfs Healthscience**: We are a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.
**Job Description:**We are seeking a highly motivated Senior Pharmacovigilance Specialist to join our SRS/FSP team. As a key member of the team, you will be dedicated to one sponsor, an international pharmaceutical company that is an industry leader.
**Key Responsibilities:**- Handling of Serious Adverse Events (SAEs) in clinical trials and spontaneous reports from the market, ensuring collection, assessment, and entry into the safety database in accordance with the TFS/client SOPs and existing demands of authorities.
- Review and approval of processed cases and AE/SAE reconciliation.
- Coding of adverse events, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary.
- Quality control and approval of coding of adverse events, medical history, and concomitant medication.
- Review and writing of the safety section in clinical study protocols.
- Review of clinical trial reports/IBs from a safety perspective.
- Writing the safety parts in PSUR/PBRER, DSURs, IND, NDA, and other safety documents.
- Literature search.
- Electronic reporting to EudraVigilance.
- Contribution to plans/instructions and SOPs for post-approval surveillance.
- Updating of templates for safety handling in specific studies/projects according to relevant SOPs.
To be successful in this role, you should have:
- Bachelor's Degree, preferably in life science or nursing; or equivalent.
- At least 3 years of experience in the position.
- Able to work in a fast-paced environment with changing priorities.
- Understanding of medical terminology and science associated with assigned drugs and therapeutic areas.
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
-
Pharmacovigilance Specialist
hace 4 semanas
Barcelona, Barcelona, España Viatris Company A tiempo completoJoin Viatris as a Pharmacovigilance Specialist and contribute to the maintenance and continuous improvement of the pharmacovigilance system at the Spanish affiliate.The successful candidate will be responsible for monitoring PV mailboxes and other communication channels for incoming ICSRs on drugs and parapharmaceuticals, performing ICSR management and CSR...
-
Global Pharmacovigilance Specialist
hace 4 días
Barcelona, Barcelona, España Instituto Grifols Sa A tiempo completoAbout the RoleWe are seeking a skilled individual to join our team as a Global Pharmacovigilance Specialist.The Key ResponsibilitiesThis role will involve providing operational support for global pharmacovigilance activities, ensuring that pharmacovigilance deliverables meet global regulatory reporting timelines and maintaining the highest quality.The Ideal...
-
Senior Pharmacovigilance Specialist
hace 4 días
Barcelona, Barcelona, España Instituto Grifols Sa A tiempo completoCompany OverviewInstituto Grifols Sa is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries.About the JobWe are...
-
Senior Pharmacovigilance Scientist
hace 4 semanas
Barcelona, Barcelona, España Neuraxpharm A tiempo completoWe are seeking a highly skilled Senior Pharmacovigilance Scientist to join our team at Neuraxpharm. As a key member of our Corporate PV department, you will play a crucial role in ensuring the safety of our medicinal products and compliance with regulatory requirements.Your Mission:As a Senior Pharmacovigilance Scientist, you will be responsible for...
-
Senior Pharmacovigilance Expert
hace 4 días
Barcelona, Barcelona, España PharmaLex A tiempo completoWe are a dynamic company with a strong commitment to innovation and growth. At Pharmalex, we believe in creating opportunities for our employees to develop their skills and expertise.Company OverviewPharmalex is one of the leading service companies for the Pharmaceutical Industry globally, specializing in all aspects of drugs and medical devices approval,...
-
Senior Pharmacovigilance Scientist
hace 4 semanas
Barcelona, Barcelona, España Neuraxpharm A tiempo completoAbout the Role:We are seeking a highly skilled Senior Pharmacovigilance Scientist to join our Corporate PV team in Barcelona, Sant Joan Despi. As a key member of our team, you will be responsible for supporting safety management activities for all Neuraxpharm products.Key Responsibilities:Support safety management activities of all Neuraxpharm products.Carry...
-
Pharmacovigilance Specialist
hace 4 semanas
Barcelona, Barcelona, España Viatris Company A tiempo completoJob SummaryWe are seeking a skilled Pharmacovigilance Technician to join our team at Viatris. The successful candidate will be responsible for maintaining and improving our pharmacovigilance system, ensuring compliance with regulatory requirements and internal standards.Key ResponsibilitiesMonitor and manage incoming ICSRs, performing case processing and...
-
Pharmacovigilance Specialist
hace 4 semanas
Barcelona, Barcelona, España Viatris A tiempo completoAbout the RoleViatris is seeking a highly skilled Pharmacovigilance Technician to join our team in Barcelona, Spain. As a key member of our Pharmacovigilance Department, you will be responsible for maintaining and improving our pharmacovigilance system.Key ResponsibilitiesMonitor PV mailbox and other communication channels for incoming ICSRs on drugs and...
-
Barcelona, Barcelona, España Qualifyze A tiempo completoCompany OverviewQualifyze is a leading company in supply chain compliance management, founded in 2019 and trusted by over 1,200 pharmaceutical and healthcare companies globally. Our digital suite of solutions connects manufacturers, suppliers, and a global network of auditors and quality experts.About the RoleWe are seeking a Senior Quality Assurance...
-
Pharmacovigilance Specialist
hace 4 semanas
Barcelona, Barcelona, España Viatris Inc. A tiempo completoThe Pharmacovigilance Technician will be responsible for maintaining and improving the pharmacovigilance system at the PV Department in Barcelona. This includes monitoring PV mailboxes, managing ICSRs, and performing quality and compliance work.Key responsibilities include:Monitoring PV mailboxes and other communication channels for incoming ICSRsManaging...
-
Senior Pharmacovigilance Strategist
hace 4 días
Barcelona, Barcelona, España Icon Clinical Plc A tiempo completoAbout ICON Clinical PlcICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence, and welcome you to be part of our mission to shape the future of clinical development.The RoleWe are seeking an experienced Senior Pharmacovigilance Strategist to join our team....
-
Pharmacovigilance Specialist
hace 3 semanas
Barcelona, Barcelona, España Viatris A tiempo completoAbout the RoleThe Pharmacovigilance (PV) Technician will play a crucial role in maintaining and improving the pharmacovigilance system at the PV Department at the Spanish affiliate. This position will be responsible for performing, planning, and assisting in the day-to-day work at the PV department.Key Responsibilities• Monitor PV mailbox and other...
-
Pharmacovigilance Specialist
hace 4 semanas
Barcelona, Barcelona, España Viatris Inc. A tiempo completoJob SummaryThe Pharmacovigilance Technician is responsible for maintaining and improving the pharmacovigilance system at the PV Department. This includes monitoring PV mailboxes, managing ICSRs, and performing quality and compliance work.Key ResponsibilitiesMonitor PV mailboxes and other communication channels for incoming ICSRsPerform, plan, and assist in...
-
Pharmacovigilance Specialist
hace 3 semanas
Barcelona, Barcelona, España Viatris A tiempo completoAbout ViatrisViatris aims to envision health not as it is but as it should be. We act with courage and our unique positioning is a source of stability in a world where healthcare needs are constantly evolving. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex...
-
Pharmacovigilance Specialist
hace 4 semanas
Barcelona, Barcelona, España Viatris A tiempo completoPharmacovigilance Technician RoleThe Pharmacovigilance (PV) Technician plays a crucial role in maintaining and improving the PV system at the PV Department at the Spanish affiliate.Key Responsibilities:Monitor PV mailbox and other communication channels for incoming ICSRs on drugs and parapharmaceuticals.Perform, plan, and assist in the day-to-day work at...
-
Senior Pharmacovigilance Director
hace 4 semanas
Barcelona, Barcelona, España Icon A tiempo completoJob SummaryThe Director of Pharmacovigilance is a key leadership role within ICON, responsible for driving the strategic direction and operational excellence of our Pharmacovigilance function. This role will lead a team of Managers and contribute to the development of client relationships to secure repeat business.Key ResponsibilitiesProvide leadership and...
-
Barcelona, Barcelona, España Icon Clinical PLC A tiempo completoAs a Senior Pharmacovigilance Leader at ICON Clinical PLC, you will play a crucial role in shaping the future of clinical development.The estimated salary for this position is €85,000 - €110,000 per annum, depending on location and experience.In this role, you will be responsible for leading our Pharmacovigilance team, ensuring that we deliver...
-
Global Pharmacovigilance Specialist
hace 4 semanas
Barcelona, Barcelona, España Grifols A tiempo completoJob DescriptionGrifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions.We believe that...
-
Pharmacovigilance and Medical Information Specialist
hace 4 semanas
Barcelona, Barcelona, España Leo Pharma A tiempo completoJob OverviewLEO Pharma is seeking a skilled Pharmacovigilance and Medical Information Officer to join our team in Barcelona, Spain. As a key member of our Iberia Medical Department, you will be responsible for ensuring the smooth operation of pharmacovigilance functions in Spain and Portugal, in accordance with regulatory requirements.Main...
-
Director, Pharmacovigilance Leader
hace 4 semanas
Barcelona, Barcelona, España Icon A tiempo completoJob SummaryThe Director of Pharmacovigilance will lead a team of pharmacovigilance experts in streamlining processes, adding value to the business, and meeting client needs. This role requires a strong leader who can provide strategic and tactical input on project planning and execution, as well as contribute to the development of new business...