EUQPPV deputy-Safety Physician R&D Center-Sant Feliu de Llobregat

Fecha:  23-jul-2022
Ubicación:  SFEL - R&D SANT FELIU DE LLOBR

Misión

Provide patients with new innovative medicines that cover current unmet medical needs having patient´s safety as first priority throughout the whole life-cycle of a product starting from the time investigational products enter into clinical development activities. 

Funciones y responsabilidades

  • EUQPPV deputy
  • Overview/medical safety responsible of  assigned products.
  • Overall medical evaluation of serious ICSRs and PSURs for assigned products. Answers to PSUR assessment reports to PRAC and RAs and ad hoc pharmacovigilance reports. Responsible to manage or write expert reports of products and responses to regulatory safety queries.
  • Perform continuous safety monitoring/safety signal detection activities and evaluation of the risk/benefit ratio for assigned products and update the corresponding governance safety Committee.
  • Maintain the Reference Safety Information (RSI) for assigned products and recommend changes, whenever necessary.
  • Assist the Local Safety Officers, partners, CROs in answering medical information questions related to safety for assigned products.
  • Participate and provide input in due-diligences of new licensing-in product acquisitions.
  • Accounable for clinical safety matters in development projects of investigational medicinal products including but not limited to protocol safety strategy, safety monitoring during clinical trials, defining AESIs etc.
  • Prepare and manage Risk Management Plan (RMP) elaboration and follow through pharmacovigilance and risk minimisation activities (e.g. PASS studies, DHPC, educational materials, etc).
  • Review DSURs , participate in safety monitoring committees and meetings.
  • Provide safety input in regulatory filing.
  • Ensure compliance with internal SOPs as well as with current pharmacovigilance regulations.  Provide training as required.
  • Implement SOPs and work practices required for compliance with the company’s internal and external corporate pharmacovigilance responsibilities.
     

Formación

Degree in Medicine
 

Conocimientos específicos

  • Specific training/experience in Pharmacovigilance/ Clinical Pharmacology/ Pharmacoepidemiology/ Clinical development
  • Basic Statistics knowledge.
  • MedDRA coding expertise
  • Digital competences
  • English a MUST and Spanish is desirable

Valores y competencias

  • Caring: We always put our patient at the center. We listen and empathize. We help each other to succeed.
  • Dedicated: We are committed and passionate. We are bold and accountable. We never give up.
  • Dynamic: We are agile and keep things simple. We empower entrepreneurial mindsets. We challenge the status quo.
  • Expert: We dare to try and learn. We are rigorous in everything we do. We strive to always be one step ahead.