Easter Seals Jobs

Medical safety management of GPV local products :

• Serve as a clinical and post-marketing medical safety expert in the country

• Accountable for all signal management activities in the country & ensures that the local product labels and risk management plans are properly aligned with the benefit risk of the products.

• Responsible of the safety surveillance of assigned GPV global and local products, in compliance with local regulations and Sanofi group procedures. This includes (but not limited to):

• Handling of local Regulatory Authorities safety queries,

• Preparation and writing of periodic safety reports,

• Management of safety signal (detection including literature screening, validation, analysis),

• Preparation and writing of risk management plans,

• Labelling updates,

• Health hazard evaluations

• Local studies documents

• Work in close collaboration with Regions Medical Safety & Processes Coordination Head to ensure appropriate assessment of Safety information related to Sanofi local products.

• Serve as the back up to country RPP/Local QPPV (if applicable by national regulations) for the products of all applicable Sanofi entities.

• Can serve as the CSH back-up where applicable

Local, Region and Global Partnership

Local:

• Serves as a back-up to local Responsible Person for Pharmacovigilance as needed

• Can act as a back-up to Country Safety Head and/or Region Safety Head when applicable

• Represent PV in interactions with local GxP and non GxP functions, to optimize coordination and collaboration in areas of overlapping interests: participate actively to local meetings/committees such as MRPQ meeting (when applicable), deliver presentations and participate in working groups.

• Build and maintain robust collaboration/interaction with the in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines, and particularly:

• Secure with Medical Information, Clinical Study Unit, Quality, Marketing and local third party (e.g. CRO, vendors) the detection and transmission to PV unit of incoming PV data in timely manner

• Contribute to the development of local implementation plan of additional Risk Minimization Measures (aRMMs) and enable its implementation by working cross-functionally with Country GBU Medical Head (or delegate), the Country Regulatory Manager and other appropriate functions.

Region/Global:

• Identify issues or dysfunction in the assigned country(ies) and escalate to Country Safety Head/CSH and/or directly to the RSH/QPPV.

• In case of PV outsourcing activities, collaborate with Regions Resources & Budget Lead in -Global PV management office to implement the best outsourced capabilities.

• Interact with the Global Safety Officer (GSO) for relevant questions related to the safety profile of Sanofi product originating from HA or any other sources.

Management responsibilities :

• Manage PV staff member(s) directly or cross-functionally:

• Provide leadership, mentorship and supervision to his/her team (e.g. leading regular team meetings) to ensure transparency and alignment on strategic direction, goals, processes and objectives

• Sets up the appropriate resources and qualification of the team, evaluates team performance and fosters training and personal development by effective talent management and recognition

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)