Medical Safety Expert

Job Description Summary
Job Description Summary
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!
The Medical Safety Expert supports Medical Safety Leads with a focus on the execution and quality of post marketing medical safety processes. In close collaboration with Medical Safety Leads and Medical Safety Group Heads, the role provides operational expertise to maintain ef-fective safety systems, drive continuous improvement, and ensure consistency, quality, and inspection readiness across activities, while also supporting the generation of reliable data and insights that contribute to the ongoing assessment of product benefit–risk.

Job Description
Medical Safety Operations (MSO) Focus

- S upport the execution of post‑marketing global and local medical safety operations (e.g., Signal Management (SD), Risk Management Plans (RMP), Aggregate Reports, Query Management, regulatory compliance), including direct support to Associate Director (AD) Signal Detection and AD RMP in line with MSO ownership of these activities, ensuring end‑to‑end process oversight and compliance with regulatory requirements.

- Support oversight of medical safety operations by monitoring performance metrics, reviewing outputs and deliverables, and ensuring adherence to quality standards, SOPs, and regulatory timelines.

- Act as a point of contact for assigned operational activities across post‑marketing medical safety processes (e.g., signal detection, aggregate reporting, regulatory response activities), while supporting the internal Sandoz and vendor teams' effectiveness through training, onboarding, and knowledge sharing to ensure consistent understanding and execution.

- Collaborate with vendors to coordinate routine operational activities, track issues, and ensure Key Performance Indicators (KPIs) and Service Level Agreements (SLAs) are met, including monthly validation of delivered data volumes.

- Contribute to the setup, maintenance, and effective use of safety systems, tools, and templates to ensure consistent, efficient, and compliant execution of post‑marketing medical safety activities.

- Assist in maintaining and continuously improving post‑marketing medical safety processes, including SOPs, working instructions, and guidance documents, and contribute to process optimization and digital initiatives.

- Ensure alignment between global and local processes. Contribute to the development and maintenance of Pharmacovigilance Agreements

- Support the exchange of information with business partners and Sandoz affiliates, as required. Support inspection and audit readiness activities, including preparation and maintenance of documentation, process descriptions, and responses to Health Authority requests.

Experience & Skills:

- Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required.

- Life-sciences background, min 4 years' experience in pharma industry is required. (Ideally in PV, Clinical Development, Regulatory Affairs, Medical Affairs or Medical Information)

- Basic experience in medical writing and safety data interpretation; familiarity with MedDRA and WHO Drug dictionaries is an advantage.

- Foundational knowledge of international pharmacovigilance legislation and medical terminology.

- Experience in interacting with service providers (Operations).

- Experience in maintenance and improvement of safety processes.

- Strong attention to detail with a quality-focused mindset and good organizational skills.

- Effective communication skills; ability to work within a matrix environment.

- Proficiency in standard digital tools (e.g., MS Office), working experience in safety systems/databases.

- Ability to work independently on assigned tasks with guidance and manage priorities under supervision.

Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people 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 careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

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.

#Sandoz

Skills Desired
Clinical Research, Clinical Trials, Functional Teams, Literature Review, Medical Records, Process Safety, Regulatory Compliance, Safety Science