Job Description Summary

-Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.

Job Description

Sandoz continues to go through an exciting period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!​

We are looking for curious, perseverant, and purpose driven candidates for the position of Patient Safety Manager, Bulgaria.

As a Patient Safety Manager, Bulgaria, you will lead and oversee pharmacovigilance activities within the local organization, ensuring alignment with the Sandoz Pharmacovigilance (PV) System, Patient Safety (PS) organization and operating model, and associated Quality systems. This role is pivotal in guaranteeing that local safety procedures are comprehensive, effective, compliant, and seamlessly integrated within the cross-functional and global-regional-local framework. As a key member of the local organization, you play a pivotal role in promoting a comprehensive understanding of the PV system and ensuring adherence to local safety requirements. Your high visibility within the organization enables you to effectively advocate for the organization ’s needs at local, regional and global levels, ensuring robust support for all safety requirements.

Major accountabilities: 

• End to end management of assigned pharmacovigilance processes across Sandoz business units with measurement of effectiveness of taken actions

• Responsible for ensuring compliance to global regulatory requirements with maximum efficiency and support impact assessments on emerging regulations

• Lead assigned cross functional patient safety projects and assigned process improvements, including IT projects/systems

• Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally

• Develop and maintain training material and communications for new starters, local organization and third party associates

• Analyze the impact of other process and organizational changes

• Work in collaboration with other functions to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements

•  In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions

• Act as a subject matter expert during audits and inspections, lead the preparation of responses to findings and the development and implementation of corrective and preventative actions

• Resolve queries from other functions related to assigned processes and act as a consultant on regulatory requirements

• Distribution of marketing samples (where applicable)

• Acts a single point of contact for local authorities

 Key performance indicators:

• Adherence to Sandoz policy and guidelines

• Project & stakeholder feedback

• Operational risk mitigation and audit/inspection findings

• Quality and timely reporting of KPI and safety reports/updates

 Minimum Requirements: 
 

  Work Experience:

• Functional Breadth

• Managing Crises

• People Challenges

• Project Management

• Operations Management and Execution

• Collaborating across boundaries

 Skills:

• Databases

• Employee Training

• Pharmacovigilance

• Project Management

• Reporting

• Safety Science

 Languages :

• English

• Bulgarian

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.

#Sandoz

Skills Desired

Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Waterfall Project Management