Chc - Pharmacovigilance Lead & Country Safety Head / São Paulo - Sp

CompetenciesJob title: CHC Pharmacovigilance Lead & Country Safety Head (PVL):Location Parque da Cidade / São Paulo - SPJob type: Permanent.Out team:Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.That's why we want to make self-care as simple as it should be by being consumer-led always, with science at our core.Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers.We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification.Join us on our mission. Health. In your hands.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 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 officeIs 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 Global Consumer Safety Head 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/ACCOUNTABILITIESLocal and Global PartnershipLocal: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 capabilitiesInteract with Global PV for any questions related to the safety profile of CHC products originating from HA or any other sourcesOrganization and maintenance of local PV Quality systemEstablish 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 appropriateEnsure 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 the zone is maintained and readily available) with key stakeholders (i.e. Quality, Medical, Regulatory)Complete in timely manner audit and inspection observations in close interaction with Global /Local FunctionsOrganization and Maintenance of PV Operating & Safety Management SystemIn compliance with PV regulatory requirements and company procedures/guidelines,Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to Global PV Operations and subsequently to external stakeholders, such as HAs, partners.Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs ,Ensure screening of local scientific / medical literature and management of relevant abstract/articlesEnsure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program...), and company sponsored digital mediaEnsure screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processesSecure that for all global/local Business Partner agreements, requiring safety provisions, a local SDEA or PV Clause is set-up, implemented and maintained as appropriate.In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), Manage contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviationsSupport the Global PV and particularly the QPPV with local safety surveillance activitiesHandle/escalate product safety alerts in timely mannerContribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert. Track the actual implementation of additional Risk Minimization Measures (aRMMs) across the zoneEnsure that PV unit is involved in reviewing relevant safety sections of local documents, owned by other affiliates entities, such as labeling, contracts with third parties and local study protocols.KEY WORKING RELATIONSHIPSRegional PV HeadCountry Medical/Regulatory/Quality Teams and Country ManagerQPPVGlobal PV Operations TeamGlobal Medical Safety TeamNetwork of PV Leads and CSHsSKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTSCompetenciesKnowledge of national (Brazilian Pharmacovigilance regulations) and international regulations regarding safety requirements as well as industry standardsLeadership skills; problem-solving, prioritize, take initiative and meet challengesGood written and verbal communication skills. Good level of speaking/writing English.Spanish will be considered as a differential.Education:Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master Degree with five or more years of pharmacovigilance/clinical development experience.Experience:Strong experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products;Appropriate experience with Regulatory Agency interactions;Previous leadership experience;Experience with Vendor Management & Oversight, preferably in an international setup.Cultural traits / P2W Behavior:Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won't: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgmentPut the interest of the organization ahead of own of those of his/her team: consider both short and long term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate levelAct in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings an external perspective into decisionsTake action and do not wait to be told what to do: take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others' advice to make bold and impactful decisions which move us forwardRequired Leadership CompetenciesStrategic Thinking - ability to evaluate relevant areas of operation, formulate objectives and set priorities in a contextually relevant way, and develop plans consistent with long-term organizational interestsBusiness Acumen – Ability to effectively use economic, financial, market, stakeholder, and industry-specific indicators to fully understand and improve business resultsJudgement- The ability to draw logical conclusions based on acquired information and analytical rigor in problem-solving, the ability to make effective decisions even when information is ambiguous or incompleteTeam Leadership – Ability to build cohesive, high-performance teams that take accountability and achieve required resultsInterpersonal relationships - treating others with courtesy, sensitivity, and respect.Change Leadership - The ability to demonstrate support and drive for innovation and organizational transformationPersonal Leadership - Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust, and accountability. Ability to put patient, stakeholder, and organizational interests above personal interestsDrive -Takes the lead and initiates activities with a high degree of passion and commitment as well as the drive, desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellenceLearning Agility – Ability to navigate first time/unfamiliar situations effectively by extrapolating from other areas of expertise and knowledge. Ability to continuously improve and develop.Management Responsibilities:Report to Regional PV Head with dotted line to Country ManagerRole impact and Scope:The performance of the PV Leads is of critical importance as these roles are driving the PV compliance level in typically one very important market with strict PV regulations as well as one or more satellite markets which are managed and overseen by the PV Leads.Pursue Progress. Discover Extraordinary: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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.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.Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!#LI-CHCPursue progress, discover extraordinaryBetter 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
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