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Patient Safety Alliance Manager (d/f/m)

Remote: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Degree in Biomedical Science or related field., Minimum 4 years experience in pharmacovigilance., At least 2 years in Patient Safety Alliance., Fluency in spoken and written English..

Key responsabilities:

  • Maintain knowledge of pharmacovigilance regulations.
  • Manage negotiations and compliance with partners.
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Novartis XLarge http://www.novartis.com
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Job description

Job Description Summary

The future is ours to shape.


 

Job Description

Sandoz, of which Lek is also a part, 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 and Lek 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 ournewSandoz and Lek! 

Your Key Responsibilities:
Your responsibilities include, but not limited to:

  • Maintain knowledge of current and developing regulations for pharmacovigilance and provide expertise and advice to all concerned Sandoz line units and external partners for Sandoz vigilance agreements, as required.
  • Take part in due diligence activities for new deals as required to assess potential partner PV systems for the impact on Sandoz enterprise and take a leading role in developing the PV collaboration strategy with partners.
  • Manage pharmacovigilance agreements with external business partners by leading and performing negotiations to define conditions of the agreement with external business partners, as well as ensure regular contact with key partners to facilitate agreement compliance and good relations.
  • Communicate requirements to Patient Safety functions and other Sandoz line units to ensure compliance with vigilance agreements, as well as ensure external business partners and Patient Safety management and QPPV are alerted on compliance and reconciliation issues and have oversight of corrective actions to improve and maintain a high level of compliance.
  • Perform timely review and updates of pharmacovigilance agreements and implementation, as well as accurate and up-to-date information of agreements in the vigilance agreement repository/ies.
  • Closely interact with local and regional business functions on new or changing deals.
  • Support inspection of Sandoz by Health Authorities, internal audits, Sandoz audits of Pharmacovigilance Agreement partners, partner inspections.

What you will bring to the role: 

  • Degree in Biomedical Science or related scientific discipline. Higher degree desirable.
  • Minimum 4 years experience in pharmacovigilance or in a regulatory/compliance related area, of those at least 2 years working in Patient Safety Alliance.
  • A thorough knowledge of the functional requirements of safety reporting, PV System and safety database, good knowledge of industry regulations and guidelines in the field of Pharmacovigilance.
  • Fluency in spoken and written English.
  • Strong interpersonal communication skills, strong negotiation and problem solving skills.
  • Experience and ability to work in matrix cross-functional environments.
  • Organizational skills, planning, prioritizing and flexibility to adjust to changing deadlines and priorities; ability to work independently and under pressure.
  • Leadership skills for leading meetings, negotiations and implementation training.


You’ll receive: 

Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities. 

 

Possible job locations: Slovenia (Ljubljana) 

 

We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by 19 December 2024. 

 

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. 

 

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! 

 

The future is ours to shape! 

 

Commitment to Diversity & Inclusion:  

Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. 

 

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

 

#Sandoz 


 

Skills Desired

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Leadership
  • Negotiation
  • Problem Solving
  • Planning
  • Communication
  • Organizational Skills
  • Physical Flexibility

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