REF 1521350
05.05.2024 | Dubai | full time
- General
- Location: Dubai
- Occupancy: full time
- To join : within 1 month
- Description
- The ultimate objective is to ensure patients, their caregivers, investigators, site staff and the clinical development team have the most up-to-date insights and information about the safety of Cellectis products and the course of action to take should concerns about patient safety arise in clinical trials.
The Pharmacovigilance Scientist will be responsible to ensure:
the central coordination and up-to-date oversight into all activities required to ensure the safety of patients that participate in Cellectis clinical trials and are exposed to Cellectis products.
the timely delivery of all required drug safety content and documents required by competent authorities from Cellectis in applicable constituencies worldwide.
the most recent and up-to-date drug safety standards, techniques, and regulations are implemented throughout the portfolio of Cellectis’s PV activities.
procedures are in place and ready for execution should concerns about patient safety arise
drug safety is pro-actively integrated into drug development activities
Responsibilities
The Pharmacovigilance Scientist will have responsibilities which include, but are not limited to, the following:
Design and perform analyses of safety information for signal detection
Manage interface with drug safety meetings (PV team, DSMB/DMC and SAC meetings)
Maintain a program plan of all activities and deliverables related to drug safety
Maintain a central repository for all matters related to drug safety
Manage the external PV services provider and account for the timely execution of contracted activities
Set up procedural standards for the conduct of PV activities across Cellectis
Ensure any PV Agreements/Safety Data Exchange Agreements with business partners comply with PV standards and are implemented and followed
Monitor compliance with regulatory and company standards for safety data management
Conduct root cause analysis of procedural deviations and implement CAPAs as required
Maintain records of PV activities at the disposal of regulatory auditors
Support internal PV audits and regulatory inspections
Author, co-ordinate and review PV-related documents including periodic reports (e.g. DSURs), SMPs, SAE reconciliation plans, RMPs, RSIs
Educate the organization on critical developments and regulatory guidance related to drug safety (FDA, EMA, MHRA, PMDA and others, where necessary)
Represent drug safety in product team meetings and all activities where drug safety is critical to the success of the company and its products
Actively pursue continuous improvement of the PV system, maintain up-to-date knowledge of international PV requirements, and complete assigned training on time
- Requirements
- Filipino preferred
- Provisions
- Salary: to be discussed
- Employment visa provided
- Medical insurance provided
- Accommodation provided
- Publisher
- direct employer
- more than 200 employees