6 Job openings found

  Designation: Senior Pharmacovigilance Associate- Global Pharmacovigilance Job Responsibility: Implement Pharmacovigilance (PV) Training project across all affiliates at Abbott under guidance of respective Country PV leads. Administrative PV activity support at EPD India like documentation, archival and filing Support during audits and Inspections Monitoring Compliance ISOtrain (training system) Coordinator for Affiliate PV team in India Presentations to senior ...

Data Analyst   Joining our pharmacovigilance team, you will support Pharma companies in handling their data related to adverse effects or drugs related problems to help them stay ahead of their competition.   Your role  As a Data Analyst, you’ll work on a project, with responsibility for:  Triage of Safety cases Book-in and case management activities Perform Data entry of all ...

Position:           Pharmacovigilence Trainee Location:          Daman Experience:       0 - 1  Years Industries:        Pharma   Responsibilities: Organize, manage and maintain a highly compliant pharmacovigilance (PV) System Should get involved in clinical trial activities Collection of information pertaining to the safety and efficacy of marketed product Revises product monograph, ...

Roles & Responsibilities:• Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR forsubmission to local and other Health Authorities.• Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.• Authoring of Signal Management Reports.• Performing literature search and validity check for the aggregate reports.• Reconciliation of relevant ...

Experience: 4–10 Years Location: Delhi / NCR Language: Japanese – JLPT N2 or N1 preferred ✅ Must-Have Skills 🔬 Core Clinical Research Skills Solid knowledge of ICH-GCP guidelines Hands-on experience with clinical trial phases (I–IV) Experience in: Site identification, initiation, monitoring, and close-out Protocol adherence and regulatory submissions SAE/AE reporting & handling deviations Patient recruitment and site coordination Documentation handling ...

Job Summary The Regulatory Affairs Manager is responsible for ensuring that products are in compliance with all applicable regulations and laws. This includes developing regulatory strategies, preparing regulatory submissions. The Manager also provides guidance to the cross functional and Area regulatory affairs team and ensures that all regulatory activities are aligned ...