Senior Global Program Safety Team Lead - CRM

Novartis; Basel; Vor Ort; CHF 169.000 - 315.000; Vollzeit

Benefits dieser Stelle

Performance-based bonus

Competitive benefits

Zusammenfassung

Novartis in Basel, Switzerland, seeks a Senior Global Program Safety Team Lead in CRM to drive safety strategies and guide development programs across cardiovascular, renal and metabolic diseases.

This hybrid role focuses on leading safety activities, collaborating with GPT/GCT/CTT, and ensuring robust safety evaluations to benefit patients globally.

Qualifikationen

• Medical degree or equivalent required; specialty board desirable.
• Minimum 5 years clinical experience postdoctoral.
• At least 7 years progressive experience in drug development including 5 years in safety in a global position.

Aufgaben

• Manage a disease area within CRM Medical Safety, providing safety contributions across the product lifecycle.
• Provide training and coaching to Medical Safety staff; support career development.
• Contribute safety input to clinical development programs and be a GPT/GCT/CTT member.
• Oversee safety signal detection, monitoring, interpretation, and regulatory communications.
• Document and track safety activities; respond to regulatory questions.
• Lead safety strategy development for health authority responses.

Kenntnisse

Leadership

Cross-functional collaboration

Safety strategy

Ausbildung

Medical degree or equivalent

PhD/PharmD or equivalent

Public Health/Epidemiology background

Jobbeschreibung

Salary Range:

CHF169,400.00 - CHF314,600.00

Job Description Summary

Take on a high impact opportunity where your leadership can help advance patient safety and improve outcomes across some of the world's most significant cardiovascular, renal and metabolic diseases.

As Senior Global Program Safety Team Lead in CRM, you will play a pivotal role within our Medical Safety organization-driving innovative safety strategies and guiding development programs that have the potential to make a meaningful difference for patients worldwide.

Job Description

Location: Basel, Switzerland

Working model: Hybrid

#LI-Hybrid

Relocation Support: This role is based in Basel , Switzerland . Novartis is unable to offer relocation support - please only apply if this location is accessible to you.

Key Responsibilities :

• Manage an efficient and successful disease area within the CRM Therapeutic Area (TA)/Development Unit (DU) Medical Safety organization, which provides robust medical and science-driven contribution to BenefitRisk evaluation throughout product lifecycle to enable Novartis to provide impactful medicines to patients worldwide
• Enhance scientific and clinical experience of Medical Safety physicians / scientists through continuous training and coaching. Prepares safety objectives and evaluates and manages performance of the Medical Safety associates within the TA/DU. Identifies talents and high potential associates and is able to defend and discuss in front of leadership team. Together with associates identifies carrier development opportunities and support associates in the carrier path
• Provide expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT) -Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management
• Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources
• Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities and for responses to inquiries from regulatory authorities or health care professionals on safety issues
• Leading the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members
• Contribute to and often leading the development of departmental and functional/business unit goals and objective

Essential Requirements

• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable
• Minimum 5 years clinical experience postdoctoral
• At least 7 years progressive experience in drug development in a major pharmaceutical company (of which 5 years in a global position), including 5 years in safety at a medical position
• Solid expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information - to include NDA submission documents
• Substantial experience in leading cross-functional, multicultural teams
• Strong experience with (safety or others) issue management
• Extensive experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publication
• Strong leadership skills including coaching; motivating and directing and fostering teamwork. Ability to develop and maintain effective working relationships with subordinates, superiors and peers
• Beneficial skills and knowledge: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)
• Strong negotiation and conflict management skills
• Strong experience with medical writing and delivering high quality documents such as RMPs, PSURs

This is your opportunity to lead at the forefront of Oncology development and influence the future of patient safety on a global scale.

Benefits & Rewards

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: 169,400 - 314,600 CHF

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, su