Pharmacovigilance Advisor

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

About the job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

In this Role

Will serve as the local PV contact for the authorities, accountable for PV inspections, and can be nominated as local Qualified Person for Pharmacovigilance (QPPV) or local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation. Work together with the Country safety head.

Main Responsibilities:

• Ensure compliance with GPV policies for all Global Business Units when applicable, as well as with the local PV regulations for Colombia
• Organize, implement and maintain a local PV system.
• Coordinate the availability and implementation of local PV unit resources, training, systems/procedures and tools.

About you

• Experience & knowledge:Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly recommended
• A minimum of experience in either pharmacovigilance or regulatory or quality or medical or clinical development is necessary
• Experience on required standards for high quality safety relevant documents, e.g. RMP, PBRER is a plus.
• Experience with Regulatory Agency interactions is a plus
• Competencies: Strong knowledge and expertise in international and national (Pharmacovigilance) regulations as well as industry standards
• Sufficient ability to interpret clinical data including safety data
• Interpersonal skills of diplomacy and team player dynamics; knowledge of and respect for cultural differences; professionalism and mediation are important
• Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure
• Ability to work in international and transversal teams.
• Education: Medical Doctor, Pharmacy Doctor, Pharmacist, Physician.
• Health Sciences PhD, Mph or master's degree.
• Language:English- Advanced (Excluding)

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!

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