PV Medical Manager – Deputy QPPV

This is a fully remote position, open to applicants in Portugal.

📋 Description

• Contribute as part of a Global Team with shared responsibility for regulatory activities related to global pharmacovigilance.

• Collaborate with the signal management team on validation activities for designated products.

• Prepare trending reports for assigned marketed products aimed at pharmacovigilance stakeholders.

• Provide insights for negotiations with regulatory bodies concerning the submission of ADE reports.

• Assist in the formulation of pharmacovigilance policies as required.

• Support the upkeep of a pharmacovigilance electronic system from the perspectives of data capture, trend analysis, and regulatory submissions.

• Serve as the Pharmacovigilance subject matter expert for assigned product group(s).

• Offer pharmacovigilance insights for advertising and promotional materials upon request.

• Engage in risk mitigation efforts to support Global Manufacturing and Quality and defend regulatory labels.

• Complete PV Data requests and Health Hazard Assessments for assigned products upon request.

• Act as the Deputy EU/UK QPPV.

⛳️ Requirements

• A minimum of a Veterinary Medicine degree (DVM, VMD).

• At least 5 years of experience in the Veterinary Pharmaceutical Industry, including veterinary pharmacovigilance within the European Union.

• Ability to review and analyze pharmacovigilance data to create trending reports.

• Familiarity with FDA/USDA and international regulations regarding Adverse Drug Event (ADE) reporting is advantageous.

• Strong interpersonal skills are essential.

• Experience with database software and pharmacovigilance systems is preferred.

🏝️ Benefits

• Competitive healthcare and retirement savings benefits.

• A diverse range of benefits, policies, and programs designed to support employee well-being in various aspects, including health, financial wellness, family, and lifestyle resources.