Job title: CHC Pharmacovigilance Lead & Country Safety Head (PVL): Location: Parque da Cidade / São Paulo - SPJob type: Permanent Our team: Opella, the Consumer Healthcare business unit of Sanofi, is the third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market. We believe in the power of self-care and its role in creating a healthier society and planet. Through our unique portfolio of over 100 brands, including global and local high-growth challengers, we help consumers take their health into their hands. This mission is supported by our 11,000-strong team and our manufacturing and innovation centers. The CHC Pharmacovigilance Lead & Country Safety Head (PVL): Is responsible for a zone, representing one or more countries.Serves as the local PV contact for authorities, accountable for PV inspections, and is nominated as local Responsible Person for Pharmacovigilance (RPP/QPPV) for applicable CHC products.Leads all PV related activities at zone level, including case management, local safety surveillance, signal detection, and risk management.Ensures compliance with Global PV policies and local regulations for CHC products.Establishes and maintains local PV systems, ensuring proper tools and training are available.Works closely with stakeholders to ensure adequate resources and budget are allocated.Builds collaboration with in-country partner functions, including Medical, Regulatory, Quality, and Commercial. KEY RESULTS/ACCOUNTABILITIES Local and Global Partnership Local: Represent PV in interactions with local GxP and non-GxP functions.Maintain collaboration with in-country partner functions for local PV activities.Build relationships with local and Global PV vendors. Global: Identify and escalate issues to senior PV Management.Collaborate with Global PV for local PV outsourcing activities.Interact with Global PV regarding safety profile queries. Organization and maintenance of local PV Quality system Implement processes in compliance with regulations and document them appropriately.Maintain local quality documents and develop local PV System Master Files.Ensure education and training on PV topics are performed.Manage local compliance metrics and document non-compliance issues.Ensure audit and inspection readiness of local PV systems. KEY WORKING RELATIONSHIPS Regional PV HeadCountry Medical/Regulatory/Quality Teams and Country ManagerQPPVGlobal PV Operations Team SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS Competencies: Knowledge of national and international pharmacovigilance regulations.Leadership skills; problem-solving and prioritization.Good written and verbal communication skills in English; Spanish is a plus. Education: Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh, or Master Degree with five or more years of pharmacovigilance experience. Experience: Strong experience with pharmacovigilance systems and product management.Experience with Regulatory Agency interactions.Previous leadership experience.Experience with Vendor Management & Oversight. Cultural traits / P2W Behavior: Push to go beyond current operations; challenge the status quo.Prioritize organizational interests over personal ones.Act in the interest of patients and customers.Take initiative and make informed decisions. Management Responsibilities: Report to Regional PV Head with a dotted line to Country Manager. Role impact and Scope: The performance of the PV Leads is critical for driving PV compliance in important markets. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
#J-18808-Ljbffr