Patient Safety Specialist

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 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

Major accountabilities:  

• To support management of operational processes in ensuring compliance with Sandoz global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Sandoz marketed and investigational products -Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Sandoz products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).

• Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.

• Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments -Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.

• Work with other local/global PV associates to ensure accurate evaluation of safety data.

• Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.

• Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.

• Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.

• Management and maintenance all relevant assigned PVO databases, if applicable.

• Develop and update training materials for pharmacovigilance -Ensure support for and close-out of audits, corrective action plan activities and Health Authority inspections.

• Provide timely, relevant information to trial coordinators, CRAs and other Sandoz staff -Distribution of marketing samples (where applicable)

 Key performance indicators: 

• Adherence to Sandoz policy and guidelines -Project and stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections

 Minimum Requirements:  
  Work Experience: 

• Functional Breadth.

• Collaborating across boundaries.

• Operations Management and Execution.

 Skills: 

• Databases.

• Employee Training.

• Filing (Documents).

• Pharmacovigilance.

• Reporting.

• Safety Science.

 Languages :

• English.

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 (hard Coded In Workday)

Skills Desired

Databases, Employee Training, Filing Documents, Pharmacovigilance, Reporting, Safety Science

---