Clinical Safety Specialist

Clinical Safety Specialist, Location: Cracow, Hybrid (3 days at the office, 2 days home office)
Clinical Operations, Full Time, Permanent role.

At Novocure, every role contributes to extending the lives of people living with cancer. As our new Clinical Safety Specialist, you’ll play a key part in this mission by supporting the implementation of safety practices throughout clinical studies by monitoring and reporting safety-related information. You’ll overseee one to multiple smaller studies or a small program, executing study-level tasks within defined safety processes.

What You’ll Do

As part of the Clinical Safety Team you will: 

• 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

• Conduct routine sponsor oversight of outsourced vendors; escalate concerns to senior staff.
• 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.
• Ensure proper maintenance and accuracy of safety report database. Performs reconciliation/review activities, ensuring data completeness and accuracy across databases.
• Ensure compliance with regulations, SOPs, and contractual obligations and stay updated on new safety regulations and guidelines; Support development of safety policies and procedures

About You 

To thrive in this role if you will need these essential qualifications:

• 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.

• Understanding of European and North American regulatory systems for clinical trials & familiarity with PV and GCP regulations in clinical research in oncology
• Strong organizational and time management skills; able to prioritize and work.
• Excellent attention to detail, written/verbal communication, and interpersonal skills.

These additional qualifications are preferred:

• Bachelor’s level degree preferably in nursing, pharmacy or other health related profession, or degree as Registered Nurse/ Medical Doctor
• Accredited GCP course is a plus .
• Previous experience with abdominal/torso trials would be an advantage.
• 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)

About us 

Novocure is a company with a powerful mission, to extend the lives of people living with some of the most aggressive forms of cancer. Here your work will have a direct impact on patients and those who care about them.  Join a team of passionate, collaborative people who support each other, challenge one another, and innovate together. Here, you’ll connect, grow, and make a real difference. We’re a company with the drive of a startup and the strength that comes with 25 years of success. 

Novocure operates at a rare crossroad, where advanced medical technology converges with cutting-edge biotechnology. We are the only company to develop and commercialize Tumor Treating Fields (TTFields), a proprietary, groundbreaking therapy designed to disrupt cancer cell division. With us you will find a unique combination of laboratory research work alongside engineering development of advanced technologies. This fusion of disciplines positions us as true pioneers in oncology innovation, leading a new frontier in the treatment of aggressive cancers. 

What We Offer 

The annual base salary ranges from 100 000 PLN- 178 500 pln gross per annum.

This pay range is the range of base pay compensation within which Novocure expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and skills demonstrated. 

This job includes the following benefits:

•  Performance related bonus
• Life Insurance
• Multisport card/Benefit system
• Private Medical care
• ..and more!

Novoflex – our trust-based hybrid work philosophy 

We offer a flexible, trust-based hybrid working model for our office-based roles. Employees are asked to be in the office an average of three days per week, with the flexibility to choose which days work best for them. We understand that life is not always predictable, so if you need to adjust your schedule, such as leaving early, starting late, or working fewer days occasionally, we trust you to balance your time in a way that works for both you and Novocure. 

Ready to Apply? 

If you're excited about this role please apply. You might be just the person we’re looking for!