Patient Safety Senior Director (Hamburg or Barcelona)

Mission

The director of patient safety at Almirall is accountable for:

• Establishing and maintain a Global/Corporate Pharmacovigilance system that protects patients and users of Almirall medical solutions.
• Acting as the EU Qualified Person for Pharmacovigilance (QPPV) and UK QPPV.
• Ensures an adequate safety profile of investigational medicinal products and helps protecting the safety and wellbeing of subjects and patients participating in development projects.
• Role open in Hamburg or Barcelona, we will consider candidates from both locations. 

Education & Experience

• Life science degree (preferably MD) with high level of pharmacovigilance expertise (minimum of 10 years)
• Knowledge of European regulatory requirements relating to PV
• PV systems experience, GVP audits and regulatory inspections experience.
• Proficient command in English, fluency in Spanish desirable
• Team management experience

Tasks and Responsibilities

• Manages the Almirall Corporate Patient Safety Team and coordinate Safety activities for all Almirall products, both investigational and marketed products. Coordinates communication of safety issues both internally and to health authorities.
• Directs the activities of CPS concerning the processing and optimal management of pharmacovigilance-related safety information on Almirall products towards internal stakeholders (i.e headquarters, management, market companies) and external stakeholders (business partners, regulatory authorities).
• Ensures proper safety surveillance of Almirall marketed products. Oversee ongoing and periodic review of safety information to detect and investigate safety signals in order to establish/maintain adequate safety profile for Almirall products; Recommends regulatory actions and risk minimisation measures as required.
• Responsible for clinical safety aspects of development projects along with clinical department since first in man studies such as: safety monitoring, B/R balance assessment, periodic safety reports (eg. DSURs) management, SAE management and Risk Management activities.
• Maintains compliance with patient safety legal requirements and international guidelines.
• Ensures that there is quality management system in place suitable for Pharmacovigilance.
• Is the European Union Qualified person responsible for Pharmacovigilance (EUQPPV) and UK QPPV.