Patient Safety Manager

Summary

Suit et audite le programme de contrôle des médicaments, produits biologiques ou médicaux de l'entreprise, dont la réception, l'évaluation, le traitement et le suivi des rapports préjudiciables. Participe à la résolution de toute obligation légale et au respect des règles gouvernementales. Assure une réception, maintenance et évaluation précises face à l'étiquetage des produits. Signale les incidents ou réactions selon les exigences des régulateurs, y compris les données des effets négatifs des essais, les sources spontanées ou sollicitées, les rapports périodiques et d'expérience. Peut fournir tendances et détection et évaluation des signaux de sécurité. Soutient toutes les activités d'essais cliniques et après vente

About the Role

Key Responsibilities:

• To be the accountable for specific operational vigilance process(es) at the Country Organization
• To mentor less experienced staff, maintaining a professional network of key contacts and role model Novartis values and behaviors.
• Ensure oversight and compliance in terms of reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN, SUSAR, PSUR, DSUR, changes in risk-benefit profile) to Local Health Authorities (LHA) according to regulatory requirements and Novartis procedures.
• Work in close collaboration other local and global medical safety functions to ensure accurate evaluation of safety data.
• Interact and exchange relevant safety information with Health Authorities, other functional groups, third-party contractors, and PS associates, as applicable.
• Monitor national pharmacovigilance regulations and provide update to global PS organization.
• Set up, update, and implement local procedures to ensure compliance with PS global procedures and national requirements.
• Ensure local PS-related RMP commitments are executed and properly documented.

Essential Requirements:

• Education : Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist)
• Excellent communications and negotiation (networking) skills.
• Quality focused and results oriented.
• 2 years' experience in pharmacovigilance or equivalent field
• Knowledge of national and international regulations for pharmacovigilance

Desirable Requirements:

• Fluent in both written and spoken English and French
• Project management skills

Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Development

Business Unit
Innovative Medicines

Location
France

Site
Paris Headquarter (Novartis Pharma S.A.S.)

Company / Legal Entity
FR12 (FCRS = FR012) Novartis Pharma S.A.S.

Functional Area
Research & Development

Job Type
Full time

Employment Type
CDI

Shift Work
No