Medical Devices Clinical Safety Scientist

Talentify; Basel; Vor Ort; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

A leading company in Basel is seeking a Medical Devices Clinical Safety Scientist to ensure safety expertise in the medical device field. The successful candidate will develop safety processes, support training initiatives, and contribute to the continuous improvement of safety standards in collaboration with various stakeholders.

Qualifikationen

• Experience in clinical safety with medical devices.
• Understanding of MD regulations and industry standards.
• Expertise in developing safety processes for MDs.

Aufgaben

• Lead development of safety processes for medical devices.
• Support training and upskilling for medical safety.
• Consult on MD-related safety matters as needed.

Kenntnisse

Drug safety

Pharmacovigilance

Cross-functional teamwork

Ausbildung

Relevant healthcare background

Biomedical research experience

Jobbeschreibung

Medical Devices Clinical Safety Scientist

Pay Competitive

Location Basel/Basel-Stadt

Employment type Other

Job Description

Req#: JP-005381560

Our client based in Basel (Switzerland) is looking for a Medical Devices Clinical Safety Scientist to bring safety expertise in support of Medical Devices (MD)

safety aspects and interact with internal stakeholders, Regulatory Authorities and Data Monitoring Committees.

Responsibilities :

• Lead/contribute to the development of safety processes for MDs in conjunction with the relevant GPOs and/or process owners, including continuous improvement of safety processes and procedural documents, for example based upon identified quality issues, audit/inspection findings, compliance and process performance metrics, deviation trends, affiliate and functional feedback.
• Support Clinical Safety resource upskilling for MDs and influence of external landscape/stakeholders e.g., committees. ● Provide support for MD training on SOPs, WIs, BIs/GDs/Business Process Documents, including implementation/cutover guidance, communication, hypercare.
• Provide specialized knowledge of MD products or therapeutic area; stay current on these topics / fields.
• Provide ad hoc consultation to safety teams on MD related matters as appropriate (e.g. for 3rd party Legal Manufacturer MDs).
• Establish and develop links with relevant stakeholders (eg, PT colleagues).
• May be expected to support other MD safety related projects and activities, e.g. due diligence evaluations; audits/inspections; CAPAs, and other projects as needed
• Collaborate/participate within other Expert Groups Trains and mentors CSC colleagues on MD related matters as needed.

Requirements :

• Relevant levels in MD safety expertise, along with an understanding of drug safety/pharmacovigilance, to ensure the integration of MD activities into the broader pharmacovigilance landscape.
• Relevant Healthcare, Scientific or biomedical research background with clinical safety experience with the use of MDs and/or combination products in the pharmaceutical/biotech or MD industry, coupled with an understanding of the biomedical technical aspects of MDs.
• Knowledge of relevant MD regulations and industry standards.
• Strong orientation towards MD safety process development/improvement and cross-functional teamwork.
• Demonstrable knowledge of MD clinical safety and relevant areas of science

Location: Basel area, Switzerland

Duration: 12 months contract

Start date: ASAP

If you feel confident about this opportunity, we encourage you to apply, or to

reach out to me via email at [e-mail].

Job Title: Medical Devices Clinical Safety Scientist

Location: Basel, Switzerland

Job Type: Contract

Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield

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