SANOFI CHC PURPOSE AND ASPIRATION At Sanofi CHC, we have one shared purpose - we work passionately, every day, to ‘serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centered around people, our customers, healthcare professionals, and our employees, across the world. We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Fast Moving Consumer Healthcare Business. We want to be market shapers and achieve category leadership in the categories that we play in - delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example. As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect, and integrity. JOB PURPOSE The CHC PV Zone Head & Country Safety Head (PVZH): - Is responsible for a zone, represeting one or more countries. - Serves as the local PV contact for the authorities, is accountable for PV inspections and is nominated as local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations. Designate a back-up who replaces him/her when he/she is out of the office - Is recognized as the key leader for all PV related activities at zone level, including but not limited to case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs market research programs and Distributor management for PV aspects. - Ensures that local PV activities across the zone are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country(ies) - Establishes and maintain robust and efficient local PV systems in the countries of the zone by ensuring the availability and implementation of proper systems/procedures tools and training. Support the QPPV in overseeing the PV activities across the zone. - Work closely with the relevant stakeholders including QPPV and CHC Head of Safety to ensure adequate resources and budget are allocated. - Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager. KEY RESULTS/ACCOUNTABILITIES Local and Global Partnership **Local**: - Represent PV in interactions with local GxP and non GxP functions, to optimize coordination and collaboration in areas of overlapping interests: - 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. - Build and maintain robust working relationship with local external PV vendors as well as Global PV vendors operating local activites. Global: - Identify issues or dysfunction in the assigned country(ies) and escalate to senior PV Management, - In case of local PV outsourcing activities, collaborate with Global PV to implement the best outsourced capabilities - Interact with Global PV for any questions related to the safety profile of CHC products originating from HA or any other sources Organization and maintenance of local PV Quality system - Establish and implement processes in compliance with regional/local PV regulations and global procedures and cooperate with the local Quality Head to document them in local Quality Documents as appropriate - Ensure maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements. - Develop and maintain the local PV System Master Files for the assigned territories as required and in accordance with local regulations and the global standards. - Ensure that education and training on PV and relevant safety topics within the local organization are performed including documentation of attendees and topics covered (i.e. PV Awareness, training of service providers and manufacturing sites) - Manage local compliance metrics generation and ensure data capture in the appropriate tools. - Document PV process non-compliance to include investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and coordinate related tracking activities with local Quality Head. - Warrant audit and inspection readiness of the local PV systems (auditable trail of all PV activities performed across