Hobson Prior are looking for a Clinical Safety Scientist to join an amazing pharmaceutical organisation on a contract basis located in Switzerland where you will be working from home. For more information, please get in touch now!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• The ideal candidate will be responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance.
• You will be responsible for the arrangement and upkeep of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB.
• The candidate will take responsibility for safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.).
• Take independent responsibility for risk management activities including preparation and maintenance of CCDS, labelling document maintenance (including IB), risk communications, RMP, REMS.
• Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action).
• Contribute to the review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests.
• Provide expert contribution to the development of the product safety strategy.
• Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.
• Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable.
• Any other assigned duties.

Key Skills:

• The ideal candidate will have demonstrated the ability to lead and influence, with and without authority, in a global matrix environment.
• You will have excellent written and verbal communication skills.
• Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.
• The candidate will be able to apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity.

Requirements:

• An education in Life Sciences.
• Minimum 5 to 7 years of relevant hands on experience in Safety/Pharmacovigilance.
• Hands on experience with clinical trial and mature products safety.
• Hands on working experience with Risk Management Plan, Protocols, DSR, DSUR, CSR, IB, Adverse Events, etc.
• The ability to demonstrate a broad understanding of the scientific aspects of safety, PV and clinical/patient risk management (e.g. via demonstrable knowledge of the application of GVP, GCP & CTR requirements) is essential.
• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
• Evidence of proactive, structured thinking with the ability to rapidly respond to an evolving and complex environment.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.