Sandoz is a global leader in the generics and biosimilars industry, delivering affordable, high-quality medicines that impact millions of lives. With a focus on innovation, sustainable growth, and fostering an inclusive work environment, Sandoz is paving the way for a healthier future. Joining Sandoz means becoming part of a dynamic and ambitious team that is dedicated to shaping the future of medicine.
Job Responsibilities
As a Patient Safety Specialist at Sandoz, you will play a crucial role in ensuring compliance with global and local pharmacovigilance (PV) standards. Your responsibilities will include:
- Operational Compliance: Supporting the management of processes to meet global/local procedures and international PV regulations.
- Adverse Event Management: Collecting, processing, documenting, and reporting adverse events (AEs) from clinical trials, post-marketing studies (PMS), Patient-Oriented Programs (POP), and registries.
- Data Accuracy: Transcribing, translating (when required), and entering serious adverse events (SAEs) and AEs into safety systems with a focus on quality and timeliness.
- Document Tracking: Recording and tracking documents like SAEs, SRs, and Investigator Notifications in collaboration with other departments.
- Safety Reporting: Managing the submission and distribution of safety updates to Local Health Authorities (LHA) and clinical operations.
- Safety Data Evaluation: Working with PV associates to ensure accurate safety data assessment.
- Regulation Monitoring: Monitoring global, regional, and national PV regulations and updating the global PVO organization.
- Procedure Development: Developing and updating local procedures to maintain compliance.
- Database Management: Maintaining assigned PVO databases effectively.
- Training: Creating and updating training materials for pharmacovigilance.
- Audit Support: Ensuring audit close-out and corrective action plan activities.
Qualifications and Skills
Essential Qualifications:
- Bachelor’s degree or higher in a relevant field.
- Experience in pharmacovigilance or related fields.
- Functional expertise in safety science and operations management.
Key Skills:
- Databases: Proficiency in maintaining and managing pharmacovigilance databases.
- Employee Training: Ability to develop and deliver effective training sessions.
- Document Filing: Efficient in maintaining accurate and organized records.
- Regulatory Knowledge: Familiarity with global and local PV regulations.
- Collaboration: Ability to work across boundaries and collaborate with diverse teams.