Descrizione : Safety Data Management Specialist. Azienda : Pfizer. Posizione : Roma, Lazio
*11 months temporary contract
- Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.
- Determination of local submission of individual and, where appropriate, aggregate safety reports.
- Carry out case processing activities;
- Review, rank, verify, process and document case-related information: event terms validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments;
- Review case criteria to determine appropriate workflow for case processing;
- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately;
- Write and edit case narrative;
- Determine and perform appropriate case follow-up, including generation of follow-up requests;
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios;
- Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation;
- Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database;
- Determine reportability of scheduled reports , ensuring adherence to regulatory requirements;
- Consistently apply regulatory requirements and Pfizer policies;
- Participate, as appropriate, in local, internal and external safety activities.
- Scientific Degree
- Experience in pharmacovigilance and/or data management preferred
- Health Care Professional or equivalent experience preferred
- Experience and skills with medical writing (an advantage)
- Demonstrated computer literacy
- Fluency in spoken and written English
- Experience in use and management of relational databases preferred
- Ability, with supervision, to solve routine problems and to surface issues constructively
- Ability to make basic decisions with an understanding of the consequences
- Ability to achieve personal objectives while meeting departmental standards of performance
- Ability to work under supervision in a matrix organization
Dealine to apply: April 8th
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