Associate Director, PS Country Operations (Insurgentes)

Associate Director, PS Country Operations (Insurgentes)

03 ago
|
Sandoz
|
Insurgentes

03 ago

Sandoz

Insurgentes

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 integral leader and pioneering provider of sustainable biosimilar and generic medicines. As we move forward on this new and ambitious path, unique opportunities will arise, both professionally and personally. Join us—the future is in our hands

Major accountabilities:
- Global and /or regional,



cross-functional leadership of assigned pharmacovigilance processes across Sandoz business units to ensure compliance with worldwide regulations with maximum efficiency -Globally responsible for compliance, quality, efficiency and management of Post Marketing and Clinical Trial adverse event handling -Lead management of activities /interfaces with other Global Line Functions management, Investigator Sites, Sandoz affiliates and Sandoz Sectors management to ensure timeliness, consistency and quality of safety information and to achieve a common understanding of other departmental needs.
- Build high performance safety teams with challenging clear objectives in alignment with Global functional objectives to facilitate implementation of strategic initiatives.
- Accountable for delivery of continuous operations ( quality and compliance) goals.
- Optimize operational efficiency and clinical trial effectiveness by ensuring speedy

📌 Associate Director, PS Country Operations (Insurgentes)
🏢 Sandoz
📍 Insurgentes

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