Patient Safety Alliance Associate (m/w)

Division Global Drug Development
Geschäftseinheit CMO & PATIENT SAFETY GDD
Standort Holzkirchen (bei München)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Unbefristet
StellenID 241926BR


Stellenbeschreibung

Patient Safety Alliance Associate (m/w), Sandoz, Holzkirchen (near Munich) Germany

Job Summary

Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives?

Look no further, apply today. Patient Safety Alliance Associate (m/w), Sandoz, Holzkirchen (near Munich) Germany.

Sandoz is currently recruiting for a Patient Safety Alliance Associate (m/w) to join the Patient Safety Team.

Job purpose

The purpose of the Patient Safety Alliance Associate role is to provide expertise and advice on pharmacovigilance and/or device vigilance for all assigned Novartis Enterprise contractual arrangements including Global and Local Vigilance Agreements and Clinical Trial Supply Agreements. Also this role supports in negotiating and maintaining global vigilance agreements with external business partners, managing these global alliances, including oversight of compliance and acting as key contact person for Chief Medical Office & Patient Safety (CMO&PS) and external customers.

Key Responsibilities

• Manage global vigilance agreements with external business partners by leading negotiations and define conditions of the agreement
• Communicate requirements to Patient Safety functions and other line units to ensure compliance with global vigilance agreements
• Advise local Patient Safety team on strategy of local vigilance agreements and support compilation
• Support and advise internal units on how to meet vigilance requirements for Clinical Trial Supply Agreements
• Maintain knowledge of regulations/guidelines for pharmacovigilance and device vigilance and provide expertise to concerned external and internal stakeholders
• Keep regular contact with key customers to facilitate agreement compliance and good relations; act as key contact person to identify needs and address resolution of issues
• Support Patient Safety Alliance Head and Compliance team to ensure external business partners and CMO&PS management are alerted to compliance and reconciliation issues and corrective actions are developed



Research & Development


Mindestanforderungen

About Sandoz

Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached well over 500 million patients. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

Benefits of Working for Sandoz

• Competitive salary
• Performance based annual bonus
• Work/life integration
• Eligible to Sandoz pension plan
• 30 working days' holiday per calendar year
• Subsidised on-site cafeteria
• Free shuttle bus between Sandoz and Holzkirchen train station
• Additional benefits

‘I came for the job, I stay for the culture’


The ideal candidate will have

• Degree in Biomedical Science or related scientific discipline
• Minimum of 3 years experience in (pharmaco)vigilance /clinical safety or in a regulatory-/compliance-related area
• Experience in clinical trial safety
• Good current knowledge of industry regulations and guidelines in the field of pharmacovigilance and/or device vigilance
• Advanced user knowledge of MS Office, SharePoint and safety databases
• Fluency in spoken and written English, knowledge of German desirable


We focus on creating an inclusive organisation and welcome people who have different knowledge, perspectives, experience and working styles from across the global population.



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