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Associate Director Global Signal Management
vor 2 Wochen
Job Description
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape
Your Key Responsibilities
Your responsibilities include, but are not limited to:
- Support the integration of local signal detection and management requirements into the global process
- Define and oversees the long-term strategy to ensure that Sandoz maintains its world class leading position in automated signal detection and evaluation.
- Lead and manage a team of external service providers who are accountable for detecting and analyzing technical signals from post-marketing surveillance in the signal management tool for all Sandoz products, Sandoz group companies or Sandoz partners (for which an agreement is in place) where Sandoz is the global safety database holder.
- Oversee and ensure maintenance of all Sandoz MedDRA Queries which are used by Patient Safety
- Drive the development and implementation of efficient workflow processes for the Safety Management Team (SMT).
- Provide strategic leadership and oversight for all signal detection and management activities conducted by the ESP, leveraging internal and external databases.
- Ensure that all new relevant medical safety signals originating from signal review or analyses from external Health Authority databases are adequately communicated to the respective Safety Lead for further escalation to the SMT.
- Partner with Safety Leads who present safety signals to various internal and external boards
- Review of Safety Signal sections of License partner agreements.
- Ensure timely and accurate communications of signals to license partners as per PVA and to PS countries.
- Support the development and customization of signal detection and management software so to contribute to it is compliance with all applicable regulatory requirements.
- Develop new approaches (including policy, methodology, process improvements) for signal detection in Safety Signal software.
- Provide expert guidance in the development of all relevant aspects of signal detection strategy using post-marketing safety databases.
- Ensure the signal management tools support the required KPIs for signal detection and management
- Have an overall understanding of the processes and software related to signal management so to ensure processes related to signal management are interconnected and streamlined as per lean principles.
- Develop metrics for and ensure compliance with business rules of signal review and provide a periodic compliance report to Patient Safety leadership.
- Represent Sandoz on external working groups related to Safety Signal Management.
- Lead talent-pipeline, onboarding, training and mentoring activities for new members.
- Lead audits and inspections as a SME for Safety Signal Management
Essential Requirements
What you'll bring to the role:
- At least 6 years' experience in pharmacovigilance operations, including some hands-on experience in performing signal detection and management.
- Additional hands-on experience in the preparation of aggregate reports, case processing, and risk management plans is a plus.
- Excellent understanding ICH GCP, GVP guidelines, local pharmacovigilance regulations and medical terminology
- Excellent understanding of signal detection process; understanding on upstream and downstream processes is a plus.
- Attention to detail, quality focused and ability to identify process interdependencies
- Strong organizational and project management skills
- Ability to operate effectively in an international and matrix environment.
- Understanding of signal detection statistical methodology
- Excellent communication (written and verbal) and presentation skills
- Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with and development of safety databases/applications/software.
- Experience with PV audits and inspections and writing and implementation of CAPA
- Problem solving and strong negotiation and conflict management skills.
- Fluency in English. Knowledge of other languages desirable.
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, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, 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 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 supported
Join us
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.
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