COUNTRY SAFETY MANAGER
About the Opportunity
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.
Key responsibilities and functions
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
Communications from local internal groups (including, but not limited to, sales representatives, medical information, or any other group that has first contact with a reporter) and from external parties about safety information can be timely reported to the PV department and collated (e.g. e-mail, post, telephone, fax) at a local PV intake point
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
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
Pharmaceutical industry bodies and patient associations
Other pharmaceutical companies and with the reporter (HCP, patient and/or consumer)
Graduate in health sciences (medical training will be valued)
Previous work experience (more than 3 years) in pharmacovigilance
Sound knowledge of the principles of pharmacovigilance
High level of Spanish and English
Level of medical competence and knowledge of industry standards
Good communication and presentation skills
What Sanofi can offer you
a generous package including flexible benefits
a healthy work-life balance throughout your career with us
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we're not there to try to solve everybody's problems. We want to focus on those areas where we know we are making a difference.
The values we live by are teamwork, courage, respect and integrity.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Apply nowJob no:517112 Work type:Full time Location:Spain Categories:Client Accounting Office Location:Madrid About TMF TMF Group is a leading global provider...
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