Gerente de Farmacovigilância

• Local: Campinas

Job Description

The Medley Pharmacovigilance (PV) Team reports to the Medley Science Affairs team and has a dotted reporting line to the Sanofi Patient Safety & Pharmacovigilance, whose (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers

The Medley Pharmacovigilance Manager ensures that local PV activities are performed in compliance with the global/regional/local PV regulations and PSPV Quality Documents (QDs) to warrant safe and appropriate use of Medley products in Brazil.

Key Responsibilities

• Accountable for Medley PV related activities in the country & ensures that the local PV teams are properly trained to manage these activities.

• Ensures inspection readiness of the Medley PV system in the country, serves as the local Medley PV contact for the local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP)

• Builds & maintains all necessary relations/collaboration with the key Medley PV department stakeholder, and with the in-country Medley partner functions (including but not limited to Medical, Regulatory, Quality, Commercial and Legal)

• Accountable for local Medley PV outsourced activities and Medley PV compliance of local partnerships

• Accountable for local Medley PV resources and budget.

• undefined

• *The responsibilities described above may also be extended to nutrivigilance, or any other nomenclatures used to define post-market monitoring of pharmaceutical products, depending on local regulations and Medley products approved in Brazil.

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:

• Experience in PV systems, regulatory agency interactions, and team management;

• Proven experience in implementing pharmacovigilance systems and managing safety-related aspects of product portfolios;

• In-depth knowledge of local pharmacovigilance regulations and standards required for high-quality safety documents, such as PBRER;

• Hands-on experience with pharmacovigilance audits and inspections; Solid experience in interactions with regulatory authorities.

Technical skills &Soft skills:

• Strong knowledge of pharmacovigilance systems & regulations; Good understanding of how to manage safety data from multiple sources; Able to evaluate & manage safety signals and define risk management activities.

• Strong leadership; Able to create networks and collaborate in an international cross-functional environment; Self–motivated, ruthlessly prioritize delivering the most value; Solution oriented & strategic thinking while keeping patients and customers top of mind; Good communicator with attention to detail while seeing the big picture; Good persuasion, negotiation, and influencing skills.

• Comply with and promote Sanofi’s Health, Safety, and Environment (HSE) policies, aiming to prevent accidents, avoid health risks, promote employee well-being, and reduce environmental impacts resulting from work activities.

Education:

• Medical Doctor, Pharmacist, Pharm D, Health Sciences PhD, MPH or master’s degree with two or more years of pharmacovigilance/clinical development experience; Business degree, e.g., MBA, is a plus.

Languages:

• Full professional English language proficiency and Portuguese.

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 Phrase 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.

#LI-LATAM

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!