Medical Safety Lead (m/f/d)

Sandoz in Deutschland; Holzkirchen; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

Sandoz in Deutschland is seeking a Safety Specialist for their growing team. This role involves managing safety strategies, conducting assessments, and providing safety insights for regulatory authorities within the pharmaceutical sector. The ideal candidate will hold a relevant degree and have significant experience in patient safety, demonstrating strong analytical and presentation skills. Employees benefit from comprehensive learning opportunities and a supportive work environment focused on personal growth.

Leistungen

30 days of annual leave

Additional rewards for special occasions

Company pension schemes

Parental leave

Bike leasing

Qualifikationen

• Minimum 4 years in patient safety.
• Experience in preparing safety assessments and regulatory reports.
• Proven expertise in safety issue management.

Aufgaben

• Drive safety strategy for assigned products and manage benefit-risk balance.
• Manage safety signals from diverse sources.
• Create compelling safety responses for regulatory authorities.

Kenntnisse

Analytical skills

Presentation skills

Interpretive skills

Ausbildung

Bachelor of Science in Pharmacy

Bachelor of Science in Nursing

PharmD

PhD or Masters in relevant field

Medical Degree (MBBS or MD)

Jobbeschreibung

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:

• Drive Safety Excellence: Lead the safety strategy for assigned products and manage benefit-risk balance of assigned products. Be the go-to expert for product RMPs, PSURs, PSUSA etc. Work seamlessly on safety tasks and share valuable safety insights with key cross functional stakeholders.
• Vigilant Monitoring: Manage safety signals for assigned products from diverse sources and present impactful assessments to key stakeholders. Deliver critical pharmacovigilance inputs for CDS updates.
• Lead Safety Responses: Create compelling safety responses for regulatory authorities, healthcare professionals, and legal queries. Provide global safety insights to our local and global stakeholders.
• Master Safety Documentation: Handle essential notifications, medical assessments. Evaluate product quality defects and recommend market actions.
• Lead & Innovate: Author / support thorough pharmacovigilance reviews, surveillance plans and clinical overviews. Guide case processing teams, provide safety inputs for clinical and regulatory deliverables including but not limited to clinical study protocols (e.g. - PASS, consortia studies etc.), clinical study reports, investigator brochure and safety management plans.
• Licensing & Acquisitions: Lead safety reviews for mergers and acquisitions, and propose strategic actions.
• Regulatory Champion: Support inspections and audits with confidence.

What you’ll bring to the role:

• Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Masters in relevant field or Medical Degree (MBBS or MD) required.
• At least 4 years in patient safety.
• Exceptional analytical, interpretive, and presentation skills.
• Experience in preparing safety assessments and regulatory reports.
• Proven expertise in safety issue management.

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
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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