Pharmacovigilance Manager II

Job title: Pharmacovigilance Manager II

• Location: São Paulo/SP

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 team dedicated to the safety of Sanofi Products in regions/countries. The PSPV Product Manager supports the Country Safety Head to ensure that local safety surveillance activities and submissions of safety related documents to local Health Authority are performed in compliance with the local and international PV regulations.

Main responsibilities:

- Supports the Country Safety Head (CSH) in ensuring that local PV activities are performed in compliance with the PSPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products on the market in Brazil.

- In collaboration with the Country Safety Head, maintains 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.

- Builds & maintains all necessary relations/collaboration with the key PSPV stakeholders as well as other CSHs, and with the in-country partner functions (including but not limited to Medical, Regulatory, Quality, Business Units, Commercial, Legal, and Country Lead), representing local PSPV in local decision-making committees/ discussions (eg: Innovations, launch excellence, shortage and recalls)   

- Manages the Local Safety Officers (LSOs) ensuring the medical safety of assigned local products under the oversight of the Regions Medical Safety Head. Depending on the characteristics of the local product, can also act as LSO, leading the safety data analysis, development of safety documents (such as PSRs, RMPs, B/R assessment, Signal Detection Report) and, when applicable, proposing actions to minimize the risk of products and maximize their benefits. 

- Contributes to the development of local RMP, taking into consideration the local context, in collaboration with the Risk Management Expert, and define the local implementation plan for the additional Risk Minimization Measures (aRMMs), by working cross functionally with Medical, Regulatory Affairs, Business and other appropriate functions.

- Contributes to the submission and launch of products, supporting the safety assessment of Innovation projects in country, ensuring the preparation of safety related documents (eg. RMP) as part of products dossier submissions and implementation of the appropriate risk management strategy for the products after its launch.

- Handles local periodic reports (eg: PSRs), from their planning until their submissions, coordinating the development of PSRs for local products in collaboration with Medical and Regulatory Affairs;

- Supports the GSO (Global Safety Officer) with local safety surveillance activities, acting as local sentinel supporting the global safety signal detection for all products registered in the country.

- Monitors continuously in-coming safety related communication to ensure their timely escalation to PSPV/Global PV entities and external stakeholders, such as HAs or partners.

- Participates in due diligence processes of acquisitions and divestments analyzing safety profile of products in scope and accurately reviewing the pertinent sections of the respective Safety Data Exchange Agreements (SDEAs), when applicable.

- When applicable, reviews relevant safety sections of product information/ packages, contracts with third parties and local study protocols.

- Supports PV audit and inspection readiness and participates in the local business continuity plan and crisis exercises.

• 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:
• Over 5 years of experience in team management.
• Proficient in pharmacovigilance systems and safety-related product management in both clinical development and marketed products
• Skilled in implementation of risk minimization measures and safety related analysis, including signal detection, and benefit-risk assessment.
• Experienced in interacting with Regulatory Agencies, presenting company´s projects, defining product´s safety monitoring strategy and responding to regulatory inquiries.
• Participation in pharmacovigilance audits and inspections.
• Familiar with standards for developing high-quality safety relevant documents, such as RMP, PBRER, signal detection reports, benefit-risk assessment.

• Soft and technical skills:
• Leadership skills, including the ability to create networks and collaborate in an international cross-functional environment, while respecting diversity, and cultural differences.
• Result-oriented, demonstrating problem solving abilities and a sense of urgency.
• Strong relationship/ negotiation skills.
• Experience working in international and transversal teams.
• In-depth knowledge of pharmacovigilance systems and regulations.
• Strong analytical skills with the ability to interpret clinical and post marketing data effectively, strategically communicating the results.
• Proficient in evaluating and managing safety signals and defining risk management activities.

• Education:
• Medical Doctor, Pharmacy Doctor, Pharmacist, Health Sciences PhD, MPh or Master Degree;
• Other medical scientific university educational background may be considered.

• Languages:
• Professional English language proficiency.

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.
• Play an instrumental role in shaping the pharmacovigilance environment, influencing the implementation of patient-centric regulations and solutions.

PursueProgress. 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!

Attention to the Phrases Below

*Always aimed at the safety and well-being of our employees, proof of COVID-19 vaccination is an essential item for all employees, being present on the list of admission documents.

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