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About the role
Key responsibilities & impact- Contributor to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance
- Collaborate with signal management team regarding validation activities for assigned products
- Prepare trending reports of assigned marketed products to the pharmacovigilance stakeholders
- Provide input for negotiations with regulatory agencies regarding submission of ADE reports
- Assist in the design pharmacovigilance policies as needed
- Assist in the maintenance of a pharmacovigilance electronic system from a data capture, trend analysis and regulatory submission perspective
- Function as Pharmacovigilance subject matter expert for assigned product group(s)
- Provide pharmacovigilance input for advertising and promotional material upon request
- Risk Mitigation in support of Global Manufacturing and Quality and Regulatory label defense activities
- Complete PV Data requests and Health Hazard Assessments for assigned products upon request
- Act as Deputy EU/UK QPPV
Requirements
What you’ll need- Minimum requirement of a Veterinary Medicine (DVM, VMD)
- 5 or more years of experience in Veterinary Pharmaceutical Industry including veterinary pharmacovigilance in the European Union
- Ability to review and analyze pharmacovigilance data to develop trending reports
- Knowledge of the FDA/USDA and international regulations on Adverse Drug Event (ADE) reporting is a benefit
- Strong interpersonal skills
- Experience with database software and pharmacovigilance systems is desirable
Benefits
Comp & perks- Competitive healthcare and retirement savings benefits
- an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources
ATS Keywords
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Hard Skills & Tools
pharmacovigilancedata analysistrending reportsrisk mitigationregulatory submissionsignal managementhealth hazard assessmentsADE reportingveterinary pharmacovigilancepharmacovigilance policies
Soft Skills
interpersonal skills
Certifications
Veterinary Medicine (DVM, VMD)