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

Mission

Under the supervision of the Head of Corporate Drug Safety:

• Provide medical scientific input in the corporate pharmacovigilance activities and monitor the B/R assessment of products under her/his responsibility.
• Work in collaboration with members of CDS and other departments within Almirall.

Tasks and Responsibilities

• Is responsible for medical assessment of Individual Case Safety Reports from any source. 
• Is responsible for the review of aggregate reports (eg. PBRERs), to prepare responses to regulatory safety queries or ad hoc pharmacovigilance reports requested; and responsible for the evaluation of the risk/benefit ratio for assigned products.
• Performs continuous safety monitoring and safety signal detection activities for assigned products and ensure Reference Safety Information for assigned products is up to date.
• Is responsible for risk management plan (RMP) elaboration and follow through of risk minimization activities for matures and investigational medicinal products (IMPs) under development. 
• Participates and provides clinical safety input for IMPs development projects, is responsible among others of the following activities: medical assessment of adverse events, medical input on safety related issues, RMP elaboration and related documents (eg. Educational materials, PASS). Review DSURs, 
• Participates in safety monitoring committees and meetings. 
• Provides safety input in regulatory filing. 
• Ensures compliance with internal SOPs as well as with current pharmacovigilance regulations. Prepares/updates SOPs related to the Medical Drug Safety Officer activities and participates in their implementation. Provide training as required.
• Is the nominated EUQPPV and UK QPPV deputy
• Supervise the compliance of safety and environmental standards by the employees in their area of responsibility, as well as identify situations or actions that may involve a risk in the processes under their responsibility, adopting or proposing the corresponding improvement actions, as applicable.
   

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.
   

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.