Multi Country Safety Head

Multi Country Safety Head

• Location: Bogotá, Colombia
• Type of role: Permanent / Full time

About the job

The Patient Safety & Pharmacovigilance (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 PV Regions group is an international, dynamic, and culturally diverse team dedicated to the safety of Sanofi Products in regions/countries.

The Country Safety Head ensures that local PV activities are performed in compliance with the global/regional/local PV regulations and PSPV QDs to warrant safe and appropriate use of Sanofi products in the assigned country (or countries for the M-CSH).

Main responsibilities:

• The face of the Safety organization in the country
• Accountable for all PV related activities in the country & ensures that the local PV teams are properly trained to manage these activities
• Ensures inspection readiness of the PV System in the country, serves as the local PV contact for the local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation (this role can be delegated as needed)
• Operates as Local Safety Officer (LSO) by managing medical safety of assigned local products under the oversight of the Regions Medical Safety Head (this role can be delegated as needed)
• 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, Commercial, Legal, and Country Lead).
• Accountable for local PV outsourced activities and PV compliance of local Partnerships
• Accountable for local PV resources and budget with both local & global supporting functions
• Multi-Country Safety Head (M-CSH) by managing the CSH(s) and overseeing the PV activities and compliance of countries under his/her perimeter

About you

Experience:

• Experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products
• Strong experience with PV Systems & Regulatory Agency Interactions
• Managerial experience in an international environment

Soft skills:

• Strong Leadership, able to create networks and to collaborate in an international cross-functional environment
• Interpersonal Relationships
• Personal Leadership
• Self–motivated, ruthlessly prioritize to deliver 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

Technical 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

Education:

• Advanced health care discipline degree (MD, PharmD, PhD, Master of Science, etc.) or equivalent qualification

Languages:

• Full professional English language proficiency

General competencies:

• As the local Responsible Person for Pharmacovigilance (RPP), the CSH must fulfill the local requirements applicable per country legislation
• The CSH must demonstrate sufficient proficiency in English (verbal and written) to accurately communicate PV information outside his/her country(ies)
• Strong knowledge and expertise in national (pharmacovigilance including medical products and vaccines, medical devices, cosmetics, nutraceuticals when relevant) regulations and international regulations as well as industry standards

Key functional competencies

• Medical Safety Landscape

Demonstrates understanding and compliance with the regulatory, therapeutic, and clinical environment in order to effectively define and re-evaluate the safety profile throughout the product’s life cycle.

Sufficient ability to interpret clinical data including safety data.

• Signal Detection:  Safety Surveillance & Data Gathering

Expertise in the collection of drug safety information from a variety of sources throughout the product life cycle to proactively detect and validate potential signals. Continuous evaluating and adopting the most suitable tools to optimize the collection of safety information and detection of signals.

• Signal Assessment & Risk Identification

Ability to evaluate safety signals to determine causality and impact of signal or risk, risk factors and confounding factors.

• Risk Management

Ability to define risk management activities and apply appropriate methods to characterize, avoid or reduce risks to patients and clinical trial subjects when applicable.

Key functional competencies (continued)

• Benefit/Risk Assessment & Optimization

Throughout the product life cycle, ability to assess identified and potential risks against known and potential benefits for individuals and populations. Skilled in the selection and usage of qualitative and quantitative methods for evaluating benefit/risk balance, depending on the product.

• Insight Generation & Customer Engagement 

Generates and incorporates safety insights to shape the development and commercialization plans, and the broader regulatory environment.

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!

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