Job Description
Position Summary Reporting to the Chief Medical Officer, the Pharmacovigilance Scientist at Cellectis will manage all activities related to the performance of drug safety at Cellectis. 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:
- Lead and oversee all activities required to ensure the safety of patients that participate in Cellectis clinical trials and are exposed to Cellectis products.
- Ensure development and completion of the timely delivery of all required drug safety content and documents required and in compliant with regulatory authorities
- the most recent and up-to-date drug safety standards, techniques, and regulations are implemented throughout the portfolio of Cellectis' 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
Position Responsibilities
- 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
Education and Experience
- MD, Hematology, Oncology; Liquid or solid tumor experience
- Minimum of 7-10 years of relevant experience in pharmacovigilance, drug safety, regulatory affairs or clinical trials
- Demonstrated experience in key activities and responsibilities for the role
Technical Skills / Core Competencies
- Strong analytical skills
- Attention to detail
- Excellent written and verbal communication
Physical Requirements
- Onsite in New York Office 4 days per week
Job Tags
Full time, Work at office,