WhatsApp Group Join Now
Telegram Group Join Now

ad
AD

Sandoz

2 - 5 Years

Telangana

B.Pharm, M.Pharm, Pharm.D, Msc, Lifesciences

Verified Job

Online Application
Centered Ad Example

Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

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:

  1. Operational Compliance: Supporting the management of processes to meet global/local procedures and international PV regulations.
  2. Adverse Event Management: Collecting, processing, documenting, and reporting adverse events (AEs) from clinical trials, post-marketing studies (PMS), Patient-Oriented Programs (POP), and registries.
  3. Data Accuracy: Transcribing, translating (when required), and entering serious adverse events (SAEs) and AEs into safety systems with a focus on quality and timeliness.
  4. Document Tracking: Recording and tracking documents like SAEs, SRs, and Investigator Notifications in collaboration with other departments.
  5. Safety Reporting: Managing the submission and distribution of safety updates to Local Health Authorities (LHA) and clinical operations.
  6. Safety Data Evaluation: Working with PV associates to ensure accurate safety data assessment.
  7. Regulation Monitoring: Monitoring global, regional, and national PV regulations and updating the global PVO organization.
  8. Procedure Development: Developing and updating local procedures to maintain compliance.
  9. Database Management: Maintaining assigned PVO databases effectively.
  10. Training: Creating and updating training materials for pharmacovigilance.
  11. 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.

Application Link

ad
AD

Popup Ad Example
Sticky Buttons
Join WhatsApp Group References Join Telegram