Patient Safety Manager (m/f/d)

Job Description Summary

In collaboration with the Senior Manager Patient Safety, 3rd party vendor and local organization establish and drive pharmacovigilance strategy and operational excellence at country level, in compliance with the national and international regulations/standards/guidelines and corporate procedures, for all marketed and investigational products under the responsibility of all Sandoz companies and divisions.

Job Description

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 are not limited to:

• Deputy of Senior Patient Safety Manager in Germany: Act as a Deputy of Senior Patient Safety Manager in Germany in all operational and leadership tasks.
• Deputy Commissioner for Graduated Plan – Medicine for HEXAL AG and 1 A Pharma GmbH: Act as Deputy Commissioner for the Graduated Plan in Germany According to the section 63 as of the Medicinal Products Act. The details are described in the section 19 of the Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV).
• Leadership: Build strong relationships with relevant functions in the affiliate organization (including but not limited to regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and others), in collaboration with the Senior Manager Patient Safety and 3rd party vendors.
• Communication flow: In collaboration with the Senior Manager Patient Safety, Sandoz regional Hubs and the 3rd party vendor operational hubs, ensure that communication flows for safety processes including any local sources of safety data and safety issues are identified and implemented.
• Management of Safety Information:
  • Management of Adverse Events: Ensure the local management of adverse event information, Identification of sources of adverse event information, Maintaining oversight on case content and reporting.
  • Management of Periodic reports: planning and oversight.
  • Management of Local Literature in collaboration with 3rd party vendor.
  • Support business in the set-up of programs and any other activities that may elicit adverse event and other safety relevant.
• Sandoz product safety profiles and related actions:
  • Health Authority Requests (and other externally generated signals): In collaboration with Senior Manager Patient Safety, 3rd party vendor, Regulatory Affairs (RA) and other functions, ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities.
  • Awareness of Sandoz product safety profiles.
  • Risk Management: Cooperation and oversight of the implementation of local RMP commitments and effectiveness checks.
  • Ensure readiness to implement ad hoc safety measures.
• QMS and supporting processes:
  • Local Procedures: Ensure the local Pharmacovigilance requirements are met. Where required, implement local procedures to supplement PS global procedures.
  • Trainings of local internal and external stakeholders on pharmacovigilance obligations.
  • Monitor internal compliance for local processing and external compliance.
  • Audits and Inspections: In cooperation with the Senior Manager Patient Safety 3rd party vendor, partner functions and management maintain audit/inspection readiness and manage local Pharmacovigilance audit/inspection.
  • Deviation and CAPA management.
  • PV Agreement.
  • Regulatory Intelligence.
  • Local 24hr accessibility: ensure that suitable local systems are in place that will allow concerned external stakeholders to report adverse events anytime.

What you’ll bring to the role:

Essential Requirements:

• Professional qualification in Health Care Sciences (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience.
• Certified level of written and spoken English.
• Good working knowledge of the local language.
• Knowledge of other languages is desirable.
• Minimum 7 years in drug safety or pharmacovigilance (preferred).
• At least 3 years of demonstrated leadership and achievement in all aspects of patient safety within a local/matrix environment in the pharmaceutical industry.
• Extensive understanding of local and regional pharmacovigilance requirements, with the ability to address complex regulatory issues.
• Proficient in pharmacovigilance processes, including compliance, databases, procedures, quality assurance, and training. Proven ability to critically evaluate and integrate data from diverse areas/domains.
• Effective communication skills with various stakeholders.
• Experience in pharmacovigilance audits and inspections.
• Demonstrated ability for innovative and strategic thinking.
• Strong planning, negotiation, organizational, and interpersonal skills.
• Proficiency in computer and IT systems.

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

Skills Desired

Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Waterfall Model