Product Safety Officer (PSO) (m/f/d) in Bremen
Our Product Safety Officer (PSO) is responsible for performing product vigilance activities within our specialized team. In this role, you will work according to international safety specific regulations, guidelines and standard operating procedures (SOPs) of GCP-Service or Sponsor.
The successful candidate will be responsible for Serious Adverse Event (SAE) Management: quality check, processing and reporting to involved parties (Sponsor, NCA, EC). You will independently perform project specific Safety related tasks on all projects responsible for, as well as other projects, when requested. In this international business, you need to speak and write German and English fluently. A third language is appreciated. A good self-confidence, good communication skills and ability to work independently are considered as very important for this job. Depending on your performance, we offer you individual possibilities to develop your career.
Duties and Responsibilities:
- Process SAE’s from clinical trial sites. Determine regulatory reporting requirements based on serious criteria, causality and whether event is anticipated per clinical protocol/IB.
- Interact with study team for the purposes of safety data collection, data reconciliation and medical coding
- Prepare safety event reports for clinical, regulatory and complaint handling submission in compliance with worldwide reporting requirements including individual expedited case reports such as USADE, SUSAR and other regulatory documents as requested.
- Identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered
- Responsible for SAE handling and reviewing according to SOP and European and regulatory requirements.
Required Qualifications and Skills:
- Master level degree in medicinal related field, natural science or any equivalent qualification and relevant work experience
- Expertise in MS Office Suite and ability to operate with general office software
- Excellent written and verbal communication skills (German, English) and interpersonal relationship skills
- Demonstrated problem-solving, critical thinking, and investigative skills
- Good self-confidence, communication skills and ability to work independently
- Attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Must be able to work in a team environment, including inter-departmental teams and representing the department on specific projects
- Good knowledge of medical terms and human anatomy
- Knowledge of Medical Device regulations, Drugs regulations, and regulatory reporting regulations
- 1 + years of Clinical Safety Management experience
- Experience in scientific/medical writing
If you are interested, send us your electronic application (with your salary expectations and earliest start date) and your CV to:
GCP-Service International Ltd. & Co.KG
Phone: +49 (0) 421 89676612
Fax: +49 (0) 421 4348659