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’ (https://www.youtube.com/watch?v=ugcobndkKKo) and check out our Diversity Equity and Inclusion initiatives at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

#LI-LATAM

#LI-HYBRID

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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)