Leadership role in maintenance of safety monitoring standards within the Clinical Development department
Maintain established infrastructure for expedited adverse event reporting to European and US regulatory authorities
Ensuring that drug safety database is continuously functional, remains validated and necessary updates performed
Prepare and review IND/NDA safety reports.
Regular review and updating of safety relevant sections in Investigator Brochures, clinical trial protocols, clinical study reports, statistical analysis plans, etc.
Maintain SOPs, policy documents and processes relevant to Pharmacovigilance and Clinical Safety Data Management
Maintain independent Data Safety Monitoring Boards responsible for overseeing the safety of subjects involved in clinical Trials
Serve as primary contact to all persons involved with the Data Safety Monitoring Boards
Primary contact for CROs regarding all safety related aspects within clinical trials
Provide scientific/medical advice within internal development projects and support of clinical development strategies as requested.
The requirements:
Medical Doctor with minimum of 2 years experience working in pharmacovigilance in the biotechnology/pharmaceutical industry
Knowledge of national and international laws, regulations and policies governing pharmacovigilance
Experience with vaccines and/or infectious diseases would be beneficial
Excellent command of English with strong written and oral skills, including experience in medical and regulatory terminology
Highly self-motivated, conscientious, meticulous individual able to work with a minimum of supervision
Team player who enjoys establishing and maintaining good working relationships
In-depth knowledge and skills in use of database applications, MS Office and other relevant software
