Head, Drug Safety Operations and Compliance Americas & ROW
443181 Head, Drug Safety Operations and Compliance Americas & ROW
MD Level
Base salary ranges at $240/250K, plus 20% target bonus.
1. Oversight drug safety operations performed at DSP Americas/ROW.
2. Direct DSP Americas/ROW in the management, collection, processing and reporting of adverse events
3. Oversight case management and operations on adverse event reports originating in Americas/ROW, ensuring consistent and quality data processing, supporting local marketing demands, and managing local safety regulatory issues.
4. Provide direction and assure regulatory compliance (timely and quality of expedited and periodic reporting), ensuring that processes, procedures and working instructions meet applicable local and international regulatory requirements and comply with global processes/procedures.
5. Provide direction for developing, maintaining and updating processes, SOPs and guidance on safety issues.
6. Coordinate with country-specific or company-specific reporting offices in the Americas/ROW region.
7. Mentor for Pharmacovigilance regulatory requirements in Americas/ROW territory that impact on global pharmacovigilance operations and systems.
8. Ensure signal detection and evaluation for local products.
9. Manage and track Key Performance Indicators (KPIs) for DSP Americas/ROW activities and reporting on performance results.
10. Establish, implement and maintain reporting procedures and safety data communication flows with affiliates, distributors and licensees.
11. Finalize and maintain appropriate agreements with license/market partners ensuring mutual exchange of safety information in compliance with global processes/procedures and regulatory requirements.
12. Prepare the DSP America/ROW monthly status reports.
13. Develop/manage/report status of the DSP North America budgeting and staffing.
14. Represent during regulatory on-site audits and inspections of DSP Americas/ROW.
15. Assign responsibilities to DSP America/ROW personnel.
Send CV to email removed or call 484-434-2972Estimated Salary: $20 to $28 per hour based on qualifications.
MD Level
Base salary ranges at $240/250K, plus 20% target bonus.
1. Oversight drug safety operations performed at DSP Americas/ROW.
2. Direct DSP Americas/ROW in the management, collection, processing and reporting of adverse events
3. Oversight case management and operations on adverse event reports originating in Americas/ROW, ensuring consistent and quality data processing, supporting local marketing demands, and managing local safety regulatory issues.
4. Provide direction and assure regulatory compliance (timely and quality of expedited and periodic reporting), ensuring that processes, procedures and working instructions meet applicable local and international regulatory requirements and comply with global processes/procedures.
5. Provide direction for developing, maintaining and updating processes, SOPs and guidance on safety issues.
6. Coordinate with country-specific or company-specific reporting offices in the Americas/ROW region.
7. Mentor for Pharmacovigilance regulatory requirements in Americas/ROW territory that impact on global pharmacovigilance operations and systems.
8. Ensure signal detection and evaluation for local products.
9. Manage and track Key Performance Indicators (KPIs) for DSP Americas/ROW activities and reporting on performance results.
10. Establish, implement and maintain reporting procedures and safety data communication flows with affiliates, distributors and licensees.
11. Finalize and maintain appropriate agreements with license/market partners ensuring mutual exchange of safety information in compliance with global processes/procedures and regulatory requirements.
12. Prepare the DSP America/ROW monthly status reports.
13. Develop/manage/report status of the DSP North America budgeting and staffing.
14. Represent during regulatory on-site audits and inspections of DSP Americas/ROW.
15. Assign responsibilities to DSP America/ROW personnel.
Send CV to email removed or call 484-434-2972Estimated Salary: $20 to $28 per hour based on qualifications.
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