Clinical Safety Specialist
Date: Oct 17, 2025
Location: PL
Company: novocure
Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer and other types of solid cancers. Currently we are looking for a Clinical Safety Specialist to our office in Cracow, Poland.
The Clinical Safety Specialist supports the implementation of safety practices throughout clinical studies by monitoring and reporting safety-related information. The role collaborates with cross-functional teams to ensure compliance with safety processes, serves as a contact for safety-related matters, and operates independently on routine safety deliverables. The specialist oversees one to multiple smaller studies or a small program, executing study-level tasks within defined safety processes.
RESPONSIBILITIES:
Study Oversight & Collaboration for assigned studies:
- Manage functional deliverables for a study, ensure milestones are met; escalate issues timely.
- Represent safety in cross-functional trial teams, with CROs, project team members, and clinical trial sites; collaborate to ensure integrated safety oversight
- Act as contact point for clinical study team regarding safety reporting or operational questions, or data requests from the biostatistics team
- Collaborate with cross-functional teams on safety-related projects and communicate safety information to internal stakeholders
- Routine sponsor oversight of outsourced vendors; escalate concerns to senior staff.
- Maintain basic medical understanding of assigned therapeutic areas and products
- Back-up support for team members; monitor PV inbox and support additional projects
Safety Monitoring & Reporting
- Monitor and support evaluation of the safety of investigational products (device and/or drug). Review and assess safety information from clinical trials to support ongoing safety activities. Identify potential safety issues and recommend solutions
- Collect, assess, and report adverse drug reactions (ADRs), serious adverse events (SAEs), and other safety information in accordance with regulatory requirements and ensure timely and accurate reporting of safety information.
- Support preparation and timely completion of established periodic reports and other defined study documents
- Contribute to authoring of non-scientific/non-medical safety-related content based on templates. May support drafting of clinical safety-related sections for safety physician review.
- Support the development of safety management plans for clinical trials.
Regulatory, Compliance & Documentation
- Assist in preparation of regulatory submissions and responses to safety queries
- Ensure proper maintenance and accuracy of safety report database. Performs reconciliation/review activities, ensuring data completeness and accuracy across databases.
- Maintains accurate records. Oversees consistency of safety-related documents. Ensures timely updates, and transparent and traceable documentation.
- Assist with preparation for and attend audits as needed
- Ensure compliance with regulations, SOPs, and contractual obligations and stay updated on new safety regulations and guidelines; Support development of safety policies and procedures
YOUR PROFILE:
- Bachelor’s level degree preferably in nursing, pharmacy or other health related profession, or degree as Registered Nurse/ Medical Doctor
- 2 years+ of experience in pharmacovigilance, clinical safety, or clinical research within pharmaceutical, biotech, or CRO settings.
- Hands-on experience with adverse event reporting, safety databases, and clinical trial safety processes.
- Familiarity with PV and GCP regulations in Europe, Asia, Latin America, North America and experience in clinical research in oncology
- Understanding of European and North American regulatory systems for clinical trials
- Accredited GCP course is a plus .
- Previous experience with abdominal/torso trials would be an advantage.
- Strong organizational and time management skills; able to prioritize and work.
- Excellent attention to detail, written/verbal communication, and interpersonal skills.
- Proficient in MS Office (Word, Excel, Outlook) and data systems; experience with clinical and safety databases is a plus.(Veeva, Argus)
- Ability to work independently and collaboratively with cross-functional and international teams.
- Fluent in English (written and spoken)
- Self-motivated, adaptable, and comfortable working with remote supervision.
BENEFITS:
- Performance related bonus
- Life Insurance
- Multisport card/Benefit system
- Private Medical care
- ..and more!
We are looking forward to receive your application to Emilia Bagińska, Senior Talent Acquisition Partner through our Applicant Portal. Please find more information about Novocure and our therapy on our website www.novocure.com.