PHARMACOVIGILANCE OFFICER

Pharmacovigilance Officer TFS HealthScience Rome, Italy Key Responsibilities Handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients’ SOPs and existing demands of the authorities; Review and approval of processed cases and AE/SAE reconciliation; Coding of adverse event, medical history and concomitant medication according to MedDRA and WHO-Drug Dictionary; QC and approval of coding of adverse event, medical history and concomitant medication; Review and write the safety section in clinical study protocols; Review of clinical trial reports/IBs from a safety perspective; Write the safety parts in the PSUR/PBRER, DSURs, IND, NDA and other safety documents; Literature search; Electronic reporting to EudraVigilance; Contribute to plans/instructions and SOPs for post approval surveillance; Updating of templates for safety handling in specific studies/projects according to relevant SOPs; May act as a Project Lead for Safety-only projects; Participate in relevant meetings.
Forward information to relevant members of the department or study team members; Provide internal support to other relevant departments; Involved in improvement projects with other relevant departments Actively contribute to the organization and development of routines to enhance the work at TFS; Validation of computer applications specific for the department with respect to drug safety requirements; Being well-informed and updated on laws, directives and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues; Education and supervision of new Drug Safety personnel; Participate in marketing activities.
Qualifications Bachelor’s Degree, preferably in life science or nursing; or equivalent; +2 years of experience in a Pharmacovigilance officer role; Able to work in a fast-paced environment with changing priorities; Understand the medical terminology and science associated with the assigned drugs and therapeutic areas.