8 Idmp Jobs

As a Senior Associate, Data Management at Amgen, you will play a crucial role in driving key business operation initiatives within Veeva RIM Vault to ensure alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations. Your expertise in Veeva RIM Vault will be instrumental in implementing and supporting regulatory processes, ensuring compliance, efficiency, and the delivery of high-quality regulatory information. Collaborating with cross-functional teams, you will guide regulatory initiatives, facilitate the adoption of new processes, and train teams to meet evolving demands in the regulatory landscape. Your contribution will be essential in shaping the ...

Summary The primary objective of this position is to serve as a consultant and advisor, offering expert guidance to enhance complex global business processes, products, and services in Regulatory Affairs. We seek a seasoned professional in GDD Regulatory Affairs who will lead both the strategic and operational implementation of Veeva Vault capabilities for Regulatory Registration Module. This role is responsible for ensuring alignment with organizational objectives, regulatory requirements, and enterprise architecture standards, whilst promoting product innovation and managing the lifecycle. As Associate Director Service Delivery, you will be responsible for leading and coordinating all phas...

Hiring for Narrative Writer-Mumbai,Pune Any Grad/PG with 5 to 10yrs in Narrative Writing in Clinical Documents, Protocols,Clinical Study Report,Narratives,Clinical StudyPharmacology Report. Salary-max 18 LPA Call Suhani-9911988552 Rukhsar-9899875055 Required Candidate profile -MW1-Clinical documents, Protocols, Clinical Study Pharmacology Report,CSR, Regulatory Affairs, Regulatory Publishing, eCTD, NEES, Docubridge. -MW2- xEVMPD, OMS,IDMP, RIM, Veeva Vault.

Good understanding about ISO IDMP standards, EMA SPOR Data and IDMP requirements. Good knowledge on , xEVMPD controlled vocabularies, Data Entry Tool (EVWEB) user manual, EMA registration process, MedDRA coding, EMA account management portal, Organisations management services (OMS) and SPOR master data. Knowledge on IDMP standards for the interpretation of entire product lifecycle: products in development, investigational products, products under evaluation and authorized products. Ensured accurate data cleansing and enrichment for CPs in PMS PUI, handled OMS,RMS and SMS requests within the SPOR database and performed data cleanup activities related to ISO IDMP and SPOR.

You have 8-12 years of experience and are looking for a permanent job opportunity. Your roles and responsibilities will include: - Experience in interface development and design. - Proficiency in Informatica. - Strong background in Oracle PL/SQL. - Familiarity with regulatory information management systems (RIMS). - Knowledge of IDMP (identification of medicinal products) standard. - Experience working in GxP environments, particularly in computer system validation. - Optional experience with ArisGlobal Total Safety suite (ARIS, LSMV). - Optional familiarity with Veeva.RIM. If you are interested in this position, please send your updated resumes to connect@datakaar.com.,

You will be responsible for handling regulatory affairs in XEVMPD (Extended Eudravigilance Medicinal Products Dictionary) and RIMS. The ideal candidate should have a minimum of 2-5 years of relevant experience in this field. Additionally, experience in veeva-vault for creating RO/SO events, XEVMPD submission, and knowledge of IDMP and QMS database will be beneficial for this role. The position is based in Mumbai.,

You should have a minimum of 8 to 12 years of experience in interface development and design, Informatica, Oracle PL/SQL, regulatory information management systems (RIMS), and familiarity with the IDMP standard. Additionally, experience in GxP environments for computer system validation is required. Knowledge of ArisGlobal Total Safety suite (ARIS, LSMV) and Veeva.RIM would be a plus. This is a permanent position. If you meet these qualifications, please submit your updated resume to connect@datakaar.com.,

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound,...