Job description
Position Overview
Pharmacovigilance Specialist is responsible for operational delivery for assigned tasks on the project level. Pharmacovigilance Specialist can act as the Primary or Secondary Project Responsible for the project assigned. Pharmacovigilance Specialists is communicating to Pharmacovigilance Team Leader/ Pharmacovigilance Manager about potential risk related to operational delivery, quality, client relationship and company reputation, as well as ad hoc project tasks and project requirements. Pharmacovigilance Specialist can be engaged in company’s procedures review and update.
Responsibilities
* Safety case reports workflow management.
* Safety case reports triage.
* Source documentation review, management and filing.
* Safety case reports data processing; SDB data entry, narrative writing, case assessment of seriousness, medical review with causality and expectedness assessment and reporting requirement assessment.
* Performing follow-up activities and query management
* Quality Control step of data entry and case processing.
* Safety case reports reconciliation.
* Line listings preparation.
Qualifications
* At least Bachelor’s Degree in life sciences field
* Minimum 1 year of experience in safety and pharmacovigilance in pharmaceutical / CRO industry or newly graduated
* Strong in verbal and written English and Italian
* MS Office expertise
* Located in Italy