Pharmacovigilance Manager II Emplois

Description du poste

Mettez votre curiosité au service d’une équipe où l’immunoscience de pointe rencontre l’innovation la plus avancée. Dans les domaines de l’oncologie, des maladies rares, de la neurologie et des vaccins, vous travaillerez à l’intersection entre la recherche en laboratoire et la découverte boostée par l’IA, tout en collaborant au-delà des frontières pour transformer des idées novatrices en impacts concrets. Que vous souhaitiez approfondir votre expertise scientifique ou évoluer en tant que leader, vous trouverez ici l’opportunité de le faire.

Responsabilités

Supports the Country Safety Head (CSH) in ensuring all local PV activities comply with PSPV policies and global/regional/local regulations, enabling safe and appropriate use of Sanofi products in Brazil, while ensuring effective collaboration with in-country functions to execute and monitor PV activities
Builds and maintains strong cross-functional collaboration with PSPV stakeholders, CSHs, and local teams (Medical, Regulatory, Quality, Commercial, Legal, etc.), representing PSPV in local decision-making bodies for assigned products
Supports product submissions and launches by preparing safety documents (e.g., RMPs) and ensuring implementation of appropriate post-launch risk management strategies
Leads local implementation of Risk Management Plans (RMPs), including defining and executing aRMM strategies, adapting to local context, and training stakeholders in collaboration with Risk Management Experts and cross-functional teams
Supports the Global Safety Officer (GSO) in local safety surveillance, contributing to signal detection, defining and executing local surveillance strategies, monitoring safety communications, and ensuring timely escalation to PSPV, global PV, health authorities, and partners
Manages local periodic reports (e.g., PSRs) end-to-end, including planning, development, coordination with Medical, Regulatory and vendors, and submission
additionally reviews safety sections of product information, contracts, and medical programs when applicable
Participates in due diligence for acquisitions/divestments by assessing safety profiles and reviewing SDEAs, and provides oversight of local medical safety activities, including acting as Local Safety Officer (LSO) when required, leading safety analyses, documentation (PSRs, RMPs, benefit-risk, signals), and defining risk minimization actions
Promote the culture of Ethics and Business Integrity in your team by serving as a role model by ensuring appropriate knowledge and adherence to the principles of ethics and integrity, Sanofi policies and codes of conduct that regulate the pharmaceutical market
Comply with and promote Sanofi Health, Safety and Environment (HSE) policies in relation to the team it manages, which includes the Road Safety Program (Road Safety) with the purpose of preventing accidents, avoiding health risks, promoting the well-being of employees, and reducing environmental impacts resulting from the execution of their work activities
Support Sanofi Diversity, Equity and Inclusion strategy and initiatives to ensure all employees and partners are treated with respect and receive equal opportunities

Exigences

Experience in Pharmacovigilance or related pharmaceutical disciplines (Medical Affairs, Quality Assurance, Regulatory Affairs), with progressive experience in managerial roles
Demonstrated expertise in pharmacovigilance systems and safety-related product management, with proven proficiency in developing high-quality safety documentation including RMPs, PBRERs, signal detection reports, and benefit-risk assessments
Strong leadership capabilities in building and directing multidisciplinary teams (example: hands-on experience implementing risk minimization measures)
Established track record of effective stakeholder engagement and regulatory liaison with national and international regulatory agencies
Proven leadership capabilities with demonstrated ability to build strategic networks and drive collaboration across international, cross-functional teams while championing diversity and cultural inclusion
Results-driven professional with strong problem-solving skills, strategic thinking, and ability to act with appropriate urgency
Excellent communication skills with the ability to convey complex information clearly to diverse audiences
Strong influencing and negotiation abilities, adept at building consensus and driving alignment across stakeholders
Extensive experience operating effectively in global, matrix, and cross-functional team environments
Advanced analytical skills with expertise in interpreting clinical and post-marketing data, translating insights into strategic recommendations and actionable communications
Bachelor´s in Health Sciences, including Pharmacy and/or Medical Doctor. Also, other medical or scientific university educational backgrounds may be considered
Conversational Portugueses and Professional English language proficiency (Required)

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Pharmacovigilance Manager II

Description du poste

Responsabilités

Exigences

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Pharmacovigilance Manager II

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