Pharmacovigilance Manager II

Descripción del puesto:

Job title: Pharmacovigilance Manager II
* Location: São Paulo

About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Patient Safety & Pharmacovigilance (PSPV) Team as Pharmacovigilance Manager II and you'll work on strategies to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers.
The PSPV team is an international, dynamic, and culturally diverse organization committed to ensuring the safety of Sanofi products across global regions and countries. The Pharmacovigilance Manager II partners with the Country Safety Head to integrate comprehensive risk management activities into product strategies while establishing robust local safety surveillance frameworks for assigned products.

About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system -and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main responsibilities:

* 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.
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Managers
* 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.

About you
* 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

Soft and technical skills:
* * 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

Education: Bachelor´s in Health Sciences, including Pharmacy and/or Medical Doctor. Also, other medical or scientific university educational backgrounds may be considered.
Languages: Conversational Portugueses and Professional English language proficiency (Required).

Why choose us?
* Bring the miracles of science to life alongside a supportive, future focused team.
* Discover endless opportunities to grow your talent and drive your
career, whether it's through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
* Help improve the lives of millions of people globally by making drug development quicker and more effective.

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 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com!

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 and check out our Diversity Equity and Inclusion actions at sanofi.com