Veterinary Pharmacovigilance Scientist - Signal Detection …, Michigan
Veterinary Pharmacovigilance Scientist - Signal Detection …, Michigan
-
Michigan, USA -
Posted: 06/08
-
Save -
Share
Description
Job Description
The position will contribute to a Global Pharmacovigilance team s\with the collective responsibilities of addressing post marketing product surveillance of an assigned product portfolio. Post-marketing product surveillance scope will include proactive product monitoring, adverse event trending, signal detection and signal management. The position will require a specialized knowledge of animal health, in addition to regulatory requirements related to signal management, epidemiological principles, and appropriate data analysis methods. This position is expected to carry out work with limited supervision and apply technical knowledge to complete work independently. This position will ensure deliverables and embracing priorities that align with promoting patient safety, effective data analysis, and cross-functional communication and collaboration. Essential duties are not limited to those described below:
1. Provide risk assessments when applicable.
2. Represent Pharmacovigilance in cross-functional product surveillance teams.
3. Author safety review sections of regulatory reports or other communication when required, including but not limited to EU Annual Statements.
4. Build and maintain technical files within the global signal management system.
5. Utilize technical tools with the Pharmacovigilance suite of software solutions.
6. Provide innovative ideas and solutions to evolving signal detection and signal management landscape.
7. Educate and train others on Global Pharmacovigilance Systems, Processes, and Procedures as applicable.
8. Author regulatory submissions associated with signal management activities, when assigned.
9. Provide regulatory guidance and documentation to icRAMS, when requested.
10. Provide regulatory input and appropriate follow-up for inspections, and internal audits and/or process reviews
11. Lead sub-teams within when assigned, to analyze processes, identify problems, and develop effective solutions/strategies
The position will contribute to a Global Pharmacovigilance team s\with the collective responsibilities of addressing post marketing product surveillance of an assigned product portfolio. Post-marketing product surveillance scope will include proactive product monitoring, adverse event trending, signal detection and signal management. The position will require a specialized knowledge of animal health, in addition to regulatory requirements related to signal management, epidemiological principles, and appropriate data analysis methods. This position is expected to carry out work with limited supervision and apply technical knowledge to complete work independently. This position will ensure deliverables and embracing priorities that align with promoting patient safety, effective data analysis, and cross-functional communication and collaboration. Essential duties are not limited to those described below:
1. Provide risk assessments when applicable.
2. Represent Pharmacovigilance in cross-functional product surveillance teams.
3. Author safety review sections of regulatory reports or other communication when required, including but not limited to EU Annual Statements.
4. Build and maintain technical files within the global signal management system.
5. Utilize technical tools with the Pharmacovigilance suite of software solutions.
6. Provide innovative ideas and solutions to evolving signal detection and signal management landscape.
7. Educate and train others on Global Pharmacovigilance Systems, Processes, and Procedures as applicable.
8. Author regulatory submissions associated with signal management activities, when assigned.
9. Provide regulatory guidance and documentation to icRAMS, when requested.
10. Provide regulatory input and appropriate follow-up for inspections, and internal audits and/or process reviews
11. Lead sub-teams within when assigned, to analyze processes, identify problems, and develop effective solutions/strategies
Highlights
-
Company nameEurofins USA PSS Insourcing Solutions -
Job positionVeterinary Pharmacovigilance Scientist - Signal Detection and Risk Management Planning
-
Flag -
Block ad
Safety Tips
Beware of ads written with poor grammar or spelling.
Related searches
More info about this ad
Veterinary Pharmacovigilance Scientist - Signal Detection … has been posted in the Kalamazoo Engineering category on Locanto.
For Kalamazoo, there are no other ads posted in this category.
There are more ads within a 10 mi radius for this category. If you want to view those ads, click here.
