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 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 follow-up for key safety information
Manage direct reports.
Responsible for ensuring recruitment, development of top safety talent and retention of high performing associates to maintain stable pharmacovigilance operations.
Ensure regular performance evaluations, development and succession planning
Manage audits and inspections.
Takes complete responsibility for timely implementation of necessary corrective and preventive actions (CAPA commitments).
Maintain inspection readiness at all times to minimize findings
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
Critical Negotiations.
People Challenges.
Operations Management and Execution.
Collaborating across boundaries.
People Leadership.
Skills
Clinical Trial.
Databases.
Employee Training.
Pharmacovigilance.
Project Management.
Reporting.
Safety Science.
Team Management.
Languages
English.
Why Sandoz
Generic and biosimilar medicines are the backbone of the global pharmaceutical industry.
Sandoz, a leader in this sector, provided more than 900 million treatments to patients in over 100 countries in ****.
Through investments in new development capabilities, production facilities, acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients access high-quality, affordable medicines in a sustainable way.
Our open and collaborative culture is powered by talented and ambitious colleagues in an agile and collegial environment with impactful, adaptable, and hybrid careers, where diversity is welcomed and personal growth is supported.
Commitment To Diversity And Inclusion
We are committed to creating an exceptional and inclusive work environment and diverse teams that represent the patients and communities we serve.
Skills Desired
Clinical Trial, Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Team Management, Waterfall Project Management
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