Manager I, Regulatory Affairs - Pharmacovigilance

Role Description

The position will contribute to a Global Pharmacovigilance team 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 :

• Contributes to post-marketing product surveillance to include but not limited to proactive product monitoring, adverse event trending, signal detection and signal management.
• Provide risk assessments when applicable.
• Represent Pharmacovigilance in cross-functional product surveillance teams.
• Author safety review sections of regulatory reports or other communication when required.
• Build and maintain technical files within the global signal management system.
• Utilize technical tools with the Pharmacovigilance suite of software solutions.
• Provide innovative ideas and solutions to evolving signal detection and signal management landscape.
• Educate and train others on Global Pharmacovigilance Systems, Processes, and Procedures as applicable.
• Author regulatory submissions associated with signal management activities, when assigned.
• Provide regulatory guidance and documentation to icRAMS, when requested.
• Provide regulatory input and appropriate follow-up for inspections, and internal audits and / or process reviews.
• Lead sub-teams within when assigned, to analyze processes, identify problems, and develop effective solutions / strategies.

Qualification Requirements :

• Degree in veterinary medicine (DVM), or other related advanced degree.
• Minimum 3 years' clinical veterinary practice or animal health experience, or similar experience in animal health
• Experience with pharmacovigilance Signal Detection / Signal Management, data analytics, statistics, and / or epidemiology, preparation of regulatory submissions, interpretation of regulations, guidelines, and policies preferred.
• Strong verbal and written communication skills, time management and organizational skills, and a demonstrated ability to work in a team environment.
• Knowledge and understanding of global veterinary pharmacovigilance regulations

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in ( Colorado) .

Base pay may vary based on location and other factors.

Base Pay Range : $86,000 - $124,000

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California) , (NJ Remote), (NY Remote), or (Washington).

Base pay may vary based on location and

other factors.

Base Pay Range : $98,000 - $141,000

This position is eligible for short-term incentive compensation. The position is also eligible for long-term incentive.

We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.

Full time

Regular

Colleague

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