Bernabé Proto Marco

Coordinate and provide scientific input in all the safety aspects of the assigned products in Development or post marketing phase:

- Strategy and Scientific input for all clinical trial documentation as well as responsible for periodic Safety evaluation and lead the Case processing.

- Responsible for Global Safety Strategy for the products in development. Definition and implementation.

- Main responsible for safety strategy and authoring of documents for regulatory submissions of new products as well as the answers of the Safety and RMP questions during authority evaluation

- Responsible implementation of the RMM

- Management of PASS studies

- Strategy, Coordination and scientific input for PSURs, DSURs, RMP, SDEA partners agreements and Signal detection for post marketing products.

- Main responsible of the products assigned in front of Questions form Authrorities, Inspections or audits.

- Responsible of RWE Safety data and integration with medical affairs department.

• Project leader in the implementation of a Signal Detection System for the early detection of adverse events related to company products. (Project Winner 1st prize R&D Amirall Innovation Awards 2013)
• Project leader in the upgrade of the Drug Safety Database (ARISg) , the project implies the interaction and coordination of some company departments as well as partners , affiliates and the safety database vendor.
• Project Manager in the implementation of the new Pharmacovigilance legislation (GPVP).
• The responsibilities include the definition, planning and coordination of the different actions thought different departments and market companies.

• Clinical Trials safety related activities: Adverse event reporting plan preparation and adverse events processing in phase III international trials (1600 patients). Collaboration with CROs and Partners.
• - Data entry of adverse reactions for Investigational and marketed products.
• Implementation of electronic transmission (e2b) of adverse reactions to regulatory authorities
• Project leader in the implementation of a new system of tracking and compliance in accordance with internal SOPs and international regulations and guidelines. Design and creation of a new tracking database.
• Preparation and distribution of Periodic Safety Update Report (PSURs)