Country Safety Manager

COUNTRY SAFETY MANAGER

About the job:
Our Team:
An interesting role has become vacant at Sanofi’s Barcelona Office. As Country Safety Manager, you collaborate with the CSH in the maintenance of a pharmacovigilance system that ensures the registration of all safety information and the design, implementation, management and control of a risk-benefit safety strategy that meets the requirements established by Global Pharmacovigilance [GPV] and the Spanish Agency of Medicine and/or other official bodies regarding the assigned products that are authorized/marketed or in the investigation phase.

Main responsibilities:
Management of operational activities

To carry out the oversight of the outsourced activities

• To ensure the qualitative and quantitative compliance of the Pharmacovigilance (PV) activities, in accordance with the legislation in force, according to the procedures of GPV and of the Spanish Agency of the Medicine and other official bodies
• Manage or assist in compliance and quality control activities
• Analyze and contribute to the annually planning of the Periodic Safety Reports (IPS)
• Planning and development/updating of Pharmacovigilance licenses and agreements (SDEA) for existing licenses

PV Quality System Management

• Ensure that processes to comply with local PV regulations and Sanofi Group's global procedures are implemented, documented and followed locally
• Preparation and implementation of safety training for company staff and personnel acting on behalf of the company
• Participate in audits as required and in the development of corrective and preventive actions, as necessary
• Development and maintenance of the local PV System Master File in accordance with the global standards

Medical and scientific safety management activities for assigned products

• Handling of responses to requests from health authorities in collaboration with GPV
• Awareness of emerging changes in the safety profiles of products is maintained
• Support the CSH in the sentinel role for safety signal detection for global products
• Diligently answer safety questions received by the PV department, consumer, health professional and other company departments
• Management of local PV Alerts in collaboration with GPV entities, the relevant medical head and local Management Group
• Leading the adaptation and implementation of Risk Management Plans at the country level supporting the CSH
• Collaborate with the CSH in the management and sending of DHPCs to Health Professionals and the identification and management of Product Alerts
• Review of documentation for clinical trials or investigator-sponsored studies. Participation in the design of the safety section of post-marketing safety studies
• Support the Iberia Local safety Officer (LSO) on the medical safety management of local products

Collaboration with medical department/business units of the assigned products

• Scientific, medical and strategic contribution and risk management as a PV local center of expertise for the products assigned in the country
• Knowledge of the products, as well as the assigned therapeutic area
• Participation in medical/product team meetings, providing value based on knowledge of the safety profile of products and competitors
• Validation prior to implementation and monitoring of Patient Programs/Assistance Programs, market research studies and digital projects to ensure proper management of safety aspects.
• Collaborate with the pre
• and post-launch activities of the products assigned in the business units together with the CSH

Support a PV Operating system ensuring that

• Participation in the Local Internet Validation Committee for all the digital projects. Validation of the contracts with the providers if any
• Ensures that Pharmacovigilance is part of the Name Patient Program Validation Committee
• Collaboration with HA and Pharma associations to monitor and influence the evolution of the local PV regulations initiated
• Be aware of both national and international legislation and recommendations on pharmacovigilance

Other activities

• Attend local and international meetings, promoted by the company or external to ensure adequate knowledge of PV
• Collaborate with the CSH in the management of specific projects assigned
• Participate in working groups and global projects
• To be compliance with regulations, procedures and legislation: To comply at all times with the regulations and procedures defined from HSE (Health Safety and Environment) in matters of Occupational Risk Prevention and the Environment, having a proactive attitude in these matters. To comply at all times with the GDPR. To comply at all times with the company's internal procedures at a local and global level

Relations with stakeholders

Regular contact with:

• Regulatory, Quality, Medical Information, CSU, Business Units, MSLs, Sales Force, Medical and Global Pharmacovigilance

Occasional contact with:

• Market Access, Legal, Public Affairs
• Pharm