Pharmacovigilance Manager

Happy Mammoth; Berlin; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Ein führendes E-Commerce-Unternehmen sucht einen erfahrenen Pharmacovigilance Manager für die Überwachung und Einhaltung der regulatorischen Anforderungen in Deutschland. Diese vollzeit Remote-Position erfordert Kenntnisse in der Pharmakovigilanz sowie Erfahrung mit den Vorschriften von TGA und FDA. Bewerber sollten über ausgezeichnete analytische Fähigkeiten und Detailgenauigkeit verfügen. Das Unternehmen bietet die Möglichkeit, Einfluss auf die Gesundheitsversorgung von Frauen zu nehmen.

Qualifikationen

• Vorherige Erfahrung in Pharmakovigilanz oder verwandter Compliance-Rolle erforderlich.
• Vertrautheit mit TGA und FDA Anforderungen ist von Vorteil.

Aufgaben

• Überwachung und Berichterstattung über alle Nebenwirkungen gemäß TGA und FDA Vorschriften.
• Aufrechterhaltung des Pharmakovigilanzsystems für Australien und die USA.

Kenntnisse

Analytische Fähigkeiten

Aufmerksamkeit zum Detail

Kenntnisse in regulatorischen Anforderungen

Ausbildung

Erfahrung in Pharmakovigilanz oder Healthcare Compliance

Jobbeschreibung

Overview

Vor 1 Tag Gehören Sie zu den ersten 25Bewerber:innen.

About Happy Mammoth: Happy Mammoth is a high-growth e-commerce company dedicated to empowering women’s health through natural, science-backed supplements focused on gut, digestive, and hormonal wellness. As a performance-driven company, we are passionate about making a meaningful, lasting impact on our customers' lives. You can learn more about us at https://happymammoth.com/.

Role: Pharmacovigilance Manager – This is a fully remote contractor role, available full-time. The role requires availability during EU hours (GMT). The manager will oversee and maintain the company’s pharmacovigilance system, while supporting the development and monitoring of a parallel system in the U.S. This position ensures compliance with regulatory requirements for safety monitoring, adverse event reporting, and risk management of therapeutic herbal supplements.

Note: This section has been reformatted for clarity and to remove extraneous boilerplate.

Responsibilities

• Monitor, evaluate, and report on all adverse events in line with TGA and FDA regulations
• Maintain and oversee the pharmacovigilance system and related processes for Australia and the U.S. regions
• Ensure timely and accurate submission of adverse event reports to regulators
• Coordinate safety data collection, case processing, and documentation for herbal and therapeutic products
• Collaborate with internal teams (quality, regulatory affairs, customer support) to ensure accurate capture of safety information
• Develop and implement pharmacovigilance SOPs and best practices
• Contribute to regulatory inspections, audits, and compliance checks
• Support ongoing risk assessment and safety surveillance activities

Major Focus Areas

• Regulatory Compliance: Maintaining compliance with TGA and FDA pharmacovigilance requirements
• Adverse Event Reporting: Timely monitoring, reporting, and follow-up on product-related adverse events
• System Oversight: Building and maintaining robust pharmacovigilance systems in Australia and the U.S
• Cross-Functional Collaboration: Working closely with internal teams to ensure seamless reporting and data integrity
• Continuous Improvement: Supporting process development, training, and system upgrades to meet evolving requirements

Ideal Background

• Previous experience in pharmacovigilance, regulatory affairs, or related healthcare compliance role
• Familiarity with TGA and FDA requirements for alternative/over-the-counter medicines
• Strong attention to detail, analytical skills, and ability to manage compliance processes