SENIOR DRUG SAFETY MANAGER
Arithmostech
Roma
20
Scarso
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Azienda: Arithmostech Roma
Esperienza: 5 anni PV Operations
Titolo di studio: Laurea in Materia Scientifica
We are experts in the Life Sciences industry & Technology.
We are a long-standing partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains.
We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations.
Job Description PURPOSE:
Assist the Pharmacovigilance & Safety Director in the management of the Regulatory Business PV projects and project teams for the delivery of high-qualityservices to Clients, in full compliance with the applicable PV Legislation, Client’s requirements and Regulatory Business Quality Standards.
Requirements ACCOUNTABILITIES:
Manages PV & Safetyprojects and/or staff allocated to those projects
Acts as Project Managerfor assigned projects/contracts and provides the PV & Safety Director withregular updates
Oversees project phasesand delivers against milestones on budget and on time
Supervises and trainsjunior staff, with a direct reporting line or according to a functionalrelationship
Participates inworkflow development and strategic planning for PV Services
Develops and implements Safety & Project Plans and Safety Management Plans for Project/ Clientspecific AE workflows and Services
Updates the PV archivewith the required documentation (either in paper or electronic)
Performs theregistration of the Company on behalf of the Client in Eudravigilance whenrequired by the project
Enters/reports ICS Rsand SUSA Rs to Eudravigilance via EVWEB (only in case he/she has been trained bya certified person or after having completed the Eudravigilance course)
Ensures the preparationand submission of PSU Rs and DSU Rs according to the relevant rules and thedeadlines agreed with the Client
Prepares and revises Safety Data Exchange Agreements/PV Agreements
Assists the P Vphysician in the Signal Detection/ Management process
Assists in thedevelopment of new standard operating procedures and work guidance and/orreview Clients SO Ps, if applicable, to ensure full compliance
Assists in ensuringaudit/inspection readiness
Ensures tracking ofcompliance metrics
Assists in identifyingand up following up corrective action plans arising from audits and inspections
Participates intraining development programs for cross-functional personnel and externalgroups in drug safety principles and practices
Assists the PV Physician in the development of Study Protocols, I Bs, IMP Ds, RM Ps
Maycover the role of QPPV and Deputy and Italian Local Contact Person for PV
BAKROUND & EXPERIENCE University Degree in Scientific Subject (such as Chemistry, CTF, Biology…. and similar)
Atleast 5 years of experience in PV Operations, including case processing, Pharmacovigilance Agreement writing, literature screening
English, Very good
GVP
Regulatory guidelinesworldwide
Regulatorynorms applicable to Pharmacovigilance
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✔ Arithmostech