Safety Data Management Specialist

Descrizione : Safety Data Management Specialist. Azienda : Pfizer. Posizione : Roma, Lazio

*11 months temporary contract

Position Purpose

  • 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.

Primary Responsibilities

  • 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.

Qualifications

  • 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

Purpose

Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Medical #LI-PFE