Associate Director Patient Safety Reg Eu - Munich, Deutschland - Sandoz International

Sandoz International

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.

This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our 'new' Sandoz

Your Key Responsibilities:

Your responsibilities include, but not limited to:

Lead the Sandoz Patient Safety activities in the region, to deliver the Sandoz Pharmacovigilance System, and associated quality management system, so that all affiliate PV processes are efficient and cost-effective, consistent with Sandoz standards, and delivering full compliance with all regulatory authority requirements worldwide.
Provide leadership and expertise for all regional and affiliate Patient Safety staff, to mentor, develop and empower them in their roles, to drive business improvement, to share best practices and to be the first point of support and escalation for any issues.
Support the affiliate patient safety officers in the execution of their responsibilities in the affiliate, including safety officers employed by 3rd party service providers, to ensure that they are successful in the delivery of their obligations and all activities well embedded in the crossfunctional and globallocal environment, and take a forwardfacing role to internal and external stakeholders (including health authorities) when needed to ensure that safety objectives are met
Maintain a strong network with leaders and key stakeholders at the local and global level as well as with external stakeholders and service providers (3rd party vendors) using strong collaboration and negotiation skills with the aim to strengthen the authority of the local safety officer and assist in the resolution of issues.
Have for operational oversight on the regional Patient Safety activities for all Sandoz group companies including external service providers (3rd party vendors) working on behalf of Sandoz in the region.
Ensure the integrity of the Patient Safety QMS, drive the collection of metrics in line with the global compliance strategy, represent the region in global governance and implement programs for continuous improvement, inspection/audit preparation and CAPA management in the region.
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

What you'll bring to the role:

Essential Requirements:

Degree in Health Sciences or higher, including medical degree, pharmacy, or nursing
Minimum 5 years medical, pharmaceutical, clinical and/or scientific research experience with at least 5 years related experience in clinical pharmacovigilance/pharmacovigilance requirements or regulatory compliance
Minimum 23 years of demonstrated leadership and accomplishment in all aspects of patient safety at the local and global level in a matrix environment in the pharmaceutical industry
Thorough understanding of clinical drug development process
Strategic and critical thinking in establishing pharmacovigilance oversight in the region
Ability to manage and develop people
Advanced leadership experience in working and leading multidisciplinary or crossfunctional team and influencing others in a matrix organization
Proven ability to work and handle multiple tasks independently and effectively
Excellent communications, interpersonal and negotiation skills (confident and articulate)
Quality and focus oriented
Results driven, selfstarter with proactive working style, committed and accountable, transparent working style under pressure
Cultural sensitivity, patient but persuasive, cultural fit with Novartis values
Planning, organizational and computer skills
Fluent in both written and spoken English
Knowledge of other languages desirable

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the posit