Safety Physician - R&D Centre - Spain

Date: 29-Jul-2022

Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain

Company: Almirall

Mission

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. 

Tasks and Responsibilities

  • Overview/medical assessment of Individual case safety reports of assigned products.
  • Overall medical evaluation of 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 inform to the 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-dilligences of new licensing-in product acquisitions.
  • Participate and provide input in development projects of investigational medicinal products by safety profile evaluation of the products, medical assessment of SUSARs and ASIME.
  • 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.

Education

  • Degree in Medicine

Specific Knowledge

  • Specific training/experience in Pharmacovigilance/ Clinical Pharmacology/ Pharmacoepidemiology/ Clinical development
  • Basic Statistics knowledge.
  • General training regarding Industry. Training on and use of safety databases
  • Basic computer skills
  • MedDRA dictionary
  • English is must and spanish is desirable

Experience

  • 1-3 years of experience in Drug Safety,  scientific departments in the pharmaceutical industry or experience in clinical drug safety in hospitals/clinics. 

Values and competencies

  • 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.