Associate Manager, Medical Safety Post Market

Location: Root D4, CH, 6039Novocure 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, ovarian cancer and other types of solid cancers.

In our Safety Team in Root, Switzerland, we are looking for a

Associate Manager, Medical Safety Post Market Surveillance and Regulatory Reporting

As part of the Global Post-Market Safety Team you will be responsible for global safety reporting activities and support global post-market surveillance activities. You will closely collaborate with the Post-Market Case processing, and Medical Review group within the team.

You ensure sound and up-to-date processes around incident reporting and periodic report compilation for all our products in relevant markets according to the applicable regulatory environment. Support the improvement and maintenance of a PMS system under EU MDR and the development of new processes for reporting and PMS activities in new markets.

**Your responsibilities**:

- Lead the Medical Safety Post-Market Reporting activities and manage the Medical Safety Reporting Specialists.
- Oversee global vigilance reporting activities (EU MDR, FDA, Health Canada, NMPA, and others) and documentation, ensure regulatory reporting compliance and keep procedures updated.
- Pro-actively maintain current knowledge of global regulations and guidelines impacting PMS and international reporting and implement changes as required to ensure an up-to-date Vigilance and Post-Market Surveillance system.
- Coordinate and assist with the data collection and creation of Periodic Safety Update Reports (PSUR), and Post-Market Clinical Follow-up (PMCF) Reports and assist with creation of according plans under EU MDR requirements, Assist with additional regulatory or internal reports as required.
- Establish relationships with internal key stakeholders and develop cross-functional collaboration to coordinate the planning, collection, and analysis of data in the post market surveillance system.

**Your profile**:

- Bachelor degree in a scientific discipline or related field
- 4+ years previous experience in a similar position with Class II/III medical devices.
- Knowledge of and experience with post market surveillance and vigilance under EU MDR requirements., additional markets are a plus (US FDA, MDSAP, NMPA, Health Canada)
- Knowledge of regulations related to regulatory reporting (e.g. EU MDR, US FDA, MDSAP, NMPA, Health Canada)
- Strong analytical and critical thinking skills with the ability to make sound judgments based on objective data and acquired knowledge
- Attention to details, with excellent organization, problem solving and influencing skills
- Fluent in English and preferably German, both written and spoken; any further languages are of benefit.
- You’re committed to adapting to dynamic circumstances with a positive attitude
- The ability to work independently with remote supervision in a diverse team across regions and functions, with the ability to lead others remotely.