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Pharmaceutical Safety / Complaint Management Specialist (m/f/d)

Dresden
Full or part-time
Permanent employee

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

Your team

Become part of our dedicated team and actively help shape the future of our company.

If you’d like to contribute your skills in an innovative environment and further your personal development, we look forward to receiving your application.
Apply now directly through our online application portal: https://rotop-pharmaka-gmbh.jobs.personio.de/

About us

We are ROTOP Pharmaka GmbH, a leading pharmaceutical manufacturer in Germany, headquartered in Dresden-Rossendorf. For more than 25 years, we have developed, manufactured, and supplied cGMP-compliant radiopharmaceuticals for diagnostics and therapy in nuclear medicine and molecular imaging – distributed to more than 40 countries worldwide.

The ROTOP brand stands for quality, reliability, and pharmaceutical expertise. As a radiopharmaceutical manufacturer, we focus on close customer relationships, collaborative partnerships, and tailored radiopharmaceutical solutions for hospitals, clinics, and research partners. Our mission: advancing the medicine of tomorrow – developed and manufactured with responsibility.

ROTOP Pharmaka stands for integrity, expertise, and commitment – from Dresden to the future of nuclear medicine.