ITech Consult AG seeks an Associate Safety Director in Basel for a full-time, on-site role within Roche’s portfolio safety team, focusing on pharmacovigilance and drug development support.
This position sits within the Portfolio Safety Scientists group, delivering pharmacovigilance expertise to various molecules in the Roche portfolio. The specialist supports both early and late-stage development, operating with a high degree of autonomy and self-direction while contributing to the broader safety team.
Responsibilities
- Track and understand the safety profile of designated products or therapeutic areas.
- Manage individual case safety reports (ICSRs) and oversee aggregate reporting tasks.
- Identify and handle signal detection and management processes.
- Contribute expert insights to the formulation of product safety strategies.
- Lead risk management duties, including maintaining the Company Core Data Sheet (CCDS), labels, risk communications, and Risk Management Plans (RMP).
- Review clinical protocols, study reports, Investigator’s Brochures, and informed consent forms to ensure they align with safety strategies.
- Provide safety science input for regulatory submissions to authorities.
- Prepare and update safety sections within the CCDS and Reference Safety Information found in Investigator’s Brochures.
- Participate in Drug Monitoring Committees and internal review meetings, offering necessary input.
- Present critical safety findings to the Drug Safety Committee, Development Review Committee, and other governance bodies.
- Independently manage safety responsibilities on study teams and in clinical safety support activities.
- Coordinate and collaborate with vendors providing Safety Science services.
Requirements
- Degree in a Life Science discipline or qualification as a healthcare professional.
- Minimum of four years of experience in drug development within the pharmaceutical sector.
- At least three years of specific experience in drug safety or pharmacovigilance.
- Fluent proficiency in English, both written and verbal.
Nice to have
- Postgraduate qualifications such as a PhD, MSc in Life Sciences, or PharmD.
What the company offers
- Staff leasing and payroll services provided at no cost to the candidate.
About the company
ITech Consult AG is a Swiss firm certified under ISO 9001:2015, with additional offices located in Germany and Ireland. The company focuses on placing highly qualified professionals in recruitment for IT, Life Science, and Engineering sectors.
- ISO 9001:2015 certified operations.
- Specialization in IT, Life Science, and Engineering recruitment.
- Presence across Switzerland, Germany, and Ireland.
How to apply
Application language: English
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