Pharmacovigilance Specialist (m/f/d)

Job description

We are seeking an experienced employee (m/f/d) for the Drug Safety / Pharmacovigilance department at the Wehrheim location, to start as soon as possible, for a global market leader in the chemical industry. The position is for a day shift.

Benefits

• Long-term employment opportunity in a company in the region
• A wide range of discounts and exclusive employee offers through Corporate Benefits
• good chances of being hired permanently at a later date
• Fair pay according to the GVP tariff, including vacation and Christmas bonuses
• Free preventive medical checkups and work clothes provided

Tasks

• Independently processing and evaluating vigilance cases and complaints for medical devices up to and including Class III
• Review of reporting requirements, as well as the preparation and timely submission of reports to national and international authorities
• Coordination and tracking of government inquiries, actions, and regulatory processes
• Conducting trend analyses and preparing trend reports, PMS plans, and periodic safety update reports (PSURs)
• Medical and technical evaluation of complaints, as well as support for Corrective and Preventive Actions (CAPA) and safety measures
• Ensuring complete, traceable, and auditable documentation of all vigilance procedures
• Maintenance and further development of vigilance processes, SOPs, and related work instructions
• Preparation of analyses, reports, and management information
• Technical coordination of the vigilance team, as well as prioritizing and managing ongoing tasks
• Organizing and facilitating team meetings, as well as coordinating relevant areas of overlap
• Support with resource planning, onboarding new team members, and optimizing existing processes

requirements

• A college degree in a natural science, technical, or medical field; alternatively, a comparable qualification with several years of professional experience in the field of medical device vigilance.
• 3 to 5 years of practical work experience in the field of medical device vigilance or post-market surveillance for medical devices
• Demonstrable experience working with medical devices, particularly Class III devices
• In-depth knowledge of the MDR and international regulatory requirements in the medical device sector, ideally with MDSAP experience
• Several years of experience in evaluating and documenting complaints, reportable incidents, and communication with regulatory authorities
• Experience in preparing regulatory submissions and handling FSCAs, PMS, and vigilance processes
• Demonstrable experience in technical leadership, team coordination, or managing pharmacovigilance teams
• Ability to actively coordinate and manage tasks, responsibilities, and priorities within a team
• Experience in change or transition situations, as well as in managing interfaces
• Very good written and spoken German and English skills
• A structured, independent, and resilient work style with a strong focus on quality and compliance