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Sandoz
Head Medical Safety Operations (M/F/D)
Posted on Nov. 30, 2024
- Holzkirchen, Germany
- 0 - 0 USD (yearly)
- Full Time
Global Job Post Template
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:
- Manages and coaches a team of Medical Safety Experts/Specialist/Associates.
- Manages the strategic planning of the activities delivered by the Medical Safety Experts/Specialist/Associates.
- Provides strategic leadership within the Medical Safety Operations to ensure compliance in Medical Safety activities and drive compliance and quality to consistently high standards.
- Liaises with the Biosimilars/Generics Medical Safety Heads to get feedback on the performance of the Medical Safety Experts and ensures adequate trainings are put in place
- Supports Biopharma/Generics Medical Safety Heads for overall training of Medical Safety staff.
- Develops effective relationships with internal to PS and external stakeholders to ensure successful execution of the Medical Safety expertise.
- Accountable for enhancement of operational process (e.g. Signal Management, Periodic reporting, Risk Management Plan) to increase productivity, efficiency and quality in order to achieve Medical Safety Excellence.
- Advises and influences the Medical Safety organization on HA regulations and industry practices through close collaboration with Patient Safety and other line functions as well as external forums where Sandoz representation is required
- Acts as a subject matter expert during audits and inspections and leads RCA and CAPA actions.
- Collaborates with External Service Providers to identify and work collaboratively towards addressing evolving needs and ensures effective vendor utilization.
- Maintain oversight on the Safety elements of the Integrated Product List and its impact on Patient Safety processes and deliverables
- Owns and maintains medical safety processes and ensures that they are up to date and in line with the HA regulations.
- Provides guidance on processes to the Countries and regions Patient safety organization as well as other functions outside Medical Safety.
- Responsible for oversight of metrics in scope of Medical Safety Operations
What you’ll bring to the role:
Essential Requirements:
- 6 years in drug development in a major pharmaceutical company (of which 5 are in a global position in safety/clinical/medical affairs or other relevant line function at an operational or medical position)
- Excellent knowledge of HA regulations and PV processes
- Demonstrated people management experience (direct/matrix)
- Strong leadership and people management skills, with ability to successfully lead, engage and develop a highly effective team
- Demonstrated track record of successful work and management of outsourced activities and proven record of excellent communication skills with vendors
- Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills
- Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure
- Quality oriented
- Good planning, organizational and computer skills
You’ll receive:
Sandoz has an employee-first approach and that’s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.
In addition to the various learning opportunities, we offer company benefits, such as:
- 30 days of annual leave
- Holiday allowance
- Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
- Company pension schemes and capital formation benefits
- Parental leave
- Other offerings, such as bike leasing
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:
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 position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Join our Sandoz Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities, join the Sandoz Network here: https://talentnetwork.novartis.com/sandoztalentpool
#Sandoz
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