Pharmacovigilance Specialist

4 settimane fa

Roma, Lazio, Italia Tn Italy A tempo pieno
Job Title: Pharmacovigilance Officer

At TFS, we are seeking a highly skilled Pharmacovigilance Officer to join our team. As a key member of our Safety team, you will be responsible for ensuring the safe use of our clients' products.

Key Responsibilities:

  • Handling of Serious Adverse Events (SAEs) in clinical trials and spontaneous reports from the market
  • Review and approval of processed cases and AE/SAE reconciliation
  • Coding of adverse events, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary
  • Quality control and approval of coding of adverse events, medical history, and concomitant medication
  • Review and writing of the safety section in clinical study protocols
  • Review of clinical trial reports/IBs from a safety perspective
  • Writing of the safety parts in PSUR/PBRER, DSURs, IND, NDA, and other safety documents
  • Literature search
  • Electronic reporting to EudraVigilance
  • Contribution 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
  • Participation in relevant meetings
  • Providing internal support to other relevant departments
  • Involved in improvement projects with other relevant departments
  • Active contribution 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
  • Participation 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
  • Understanding of medical terminology and science associated with the assigned drugs and therapeutic areas

What We Offer:

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.

About Us:

TFS is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and functional service (FSP) solutions. We build solution-driven teams working towards a healthier future.

Our Core Values:

Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction.

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