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Safety Management Lead
il y a 1 mois
We are seeking a highly skilled Clinical Operations Manager to join our team. As a key member of our pharmacovigilance team, you will be responsible for managing the process for medical safety follow-up queries for ICSRs from interventional clinical trials and non-interventional post-authorization studies.
Key Responsibilities:
* Oversee SAE reconciliation activities (interface to Global Data Management) for company sponsored phase I to IV clinical trials and non-interventional post-authorization studies.
* Contribute to defining and implementing clinical trial safety-related activities in alliance with relevant partners/service providers of sponsor and alignment of guidelines and processes related to clinical trial safety management with existing GDS processes.
Requirements:
* Health Care Professional with extensive work experience in pharmacovigilance area, clinical development, project management, IT Systems.
* Fluent in written and spoken English.
* Proven project and process management skills.
* Several years of professional experience (5-7 years) in Drug Safety/Clinical Trial Safety Management.
* Excellent communication skills in an international environment.
What We Offer:
* A competitive salary and a range of additional benefits, including health insurance, retirement planning, and a global employee assistance programme.
* Opportunities for professional growth and development in a dynamic and supportive team environment.
* A chance to work with a leading company in the energy industry, with a strong commitment to safety and sustainability.
