Senior Patient Safety Manager

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

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.

EEO Statement:

Sandoz Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

Sandoz Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please connect with us outling the job requisition number in your message.
 

Salary Range

Skills Desired

Clinical Trial, Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Team Management, Waterfall Project Management