1 - 6 years

0 - 3 Lacs

Bengaluru

Hybrid

Key Responsibilities: Participates in the estimation of activities, owns technical implementation of the SaaS application, and responsible for the design, configuration and integration for new and modified features for CTMS/eTMF and other Veeva Vaults. This role will have a keen focus to detail through ensuring Veeva applications is deployed using the framework of the Veeva Vault configuration standards and best practices. Works closely with business to understand the business requirements. Thinks critically to help them design the solution they actually need; not just the solution they think they need. Participates in the requirements workshops, design, prototype, configure and document Veeva solutions. Implements Veeva suite of application to meet the business, functional, security and integration requirements either via configuration or custom development using Veeva Vault SDK. Participates in the testing and validation activities by helping in the creation and review of test scenarios, data staging, test executions and validation documents. Works with the Veeva support teams to provide technical solutions to production issues/integration issues. Experience: Experience working with or for Life Sciences companies; including, Pharmaceutical, Biotechnology, Healthcare, or Medical Device organizations with knowledge of drug development processes and regulatory submissions Solid experience in configuration in Veeva Vault and a strong learning attitude towards other vaults in Veeva. Exposure in Veeva Vault Data Model - Understanding of Products, eTMF, Clinical Studies, Sites. System implementation experience as developer for Veeva application. Desirable experience working with Veeva Vault SDK to deliver custom solutions by extending the application capabilities. Fair understanding of Veeva Vault data model, data loader and migration tools and technologies Understand and implement Veeva integrations (Vault to Vault / Vault to other systems or middleware like MuleSoft) Understanding of health care regulations, international regulations, and privacy controls Basic Qualifications : Bachelors Degree (or equivalent work experience) 3+ years of experience in Veeva application configuration/development Strong teamwork, self-management, problem-solving abilities Excellent oral and written communication skills Trained and Certified in Veeva Vault

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Life Sciences : Pharmacovigilance Aggregate Reporting : Apply Now Outpace Consulting Services

6 - 11 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

Work from Office

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

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