Your chance with us
Would you like to become part of an internationally active company in a future-proof industry?
Due to our continuous growth, we are offering a permanent position in a modern work environment surrounded by nature (01328 Dresden). As a Drug Safety / Complaint Management Specialist (m/f/d), you can expect exciting responsibilities, flexible work schedules, and attractive benefits for an optimal work-life balance.
More than just a job
- A permanent position at a future-proof, internationally active company
- Flexible work schedules to help you best balance family and career
- 30 vacation days to recharge
- 10 paid days off to care for a sick child, to support your family
- A modern workplace (e.g., height-adjustable desks) surrounded by nature
- Company parking and electric vehicle charging stations
- 3 days off at the company’s discretion / “K.O.” days
- Access to a diverse selection of attractive benefits via our ROTOP Benefits Portal
- Job-Rad and Jobticket for sustainable mobility
- Team-building company events to foster a strong sense of community
- Diverse career and development opportunities and additional benefits
Your tasks
- Drug Safety: Receiving and processing adverse event reports (ICSRs), including follow-up, as well as conducting regular literature reviews and data reconciliations with international sales partners
- Drug Complaints: Recording, coordinating, and documenting quality-related complaints in close collaboration with internal departments, customers, and international sales partners
- Medical and Pharmaceutical Inquiries: Coordinating and handling technical inquiries in consultation with customers and internal specialist departments
- Documentation and Compliance: Creating and maintaining Standard Operating Procedures (SOPs) and other quality-related documents, contributing to the further development of internal processes, and providing support for training sessions, audits, and inspections
- Career Prospects: With the appropriate qualifications, there is the potential to assume the role of a Phase Plan Officer (§ 63a AMG) and/or Information Officer (§ 74a AMG).
Your profile
- Degree: A completed degree in pharmacy or another scientific or medical field
- Professional Experience: Ideally, initial practical experience in the pharmaceutical industry, particularly in pharmacovigilance, pharmaceutical complaint handling, quality management, or customer service
- Regulatory Knowledge: Initial experience with the responsibilities of a Step Plan Officer or Information Officer, or knowledge of the relevant legal and regulatory requirements, is desirable
- Technical expertise: Knowledge in the field of radiopharmaceuticals is an advantage but not a requirement
- Language skills: Very good written and spoken German and English
- Work style and personal skills: A structured, meticulous, and independent work style, as well as strong communication skills, a passion for interdisciplinary collaboration, the ability to work well in a team, and a willingness to pursue professional development