We are looking for a
Safety Associate II and/or Senior Safety Associate
and welcome candidates who are interested in a position as Safety Associate II with the possibility to grow into the position as Senior Safety Associate according to your qualification.
The purpose of this position is to process serious adverse events and adverse events (SAE/AE) data obtained in clinical trials and spontaneous reports according to applicable regulations and guidelines, standard operating procedures (SOPs) and project requirements.
Your responsibility: In principle you review and process serious adverse events (SAE) information received from Investigator sites and adverse events (AEs) from post marketing sources. You prepare safety data reports for submissions to clients and assist in the preparation of expedited Safety Reports for submission to Regulatory Authorities. You assist in the compilation of regulatory submissions, i.e., Annual Reports, Periodic Safety Update Reports, further you assist the safety lead for projects – for the set-up, project management and client liaison- Literature searches and assistance in SAE reconciliation are also tasks among your responsibility as well as to maintain your current knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and pharmacovigilance reporting.
To achieve the more senior level of this position you should be able to
Your background: You have a Bachelor’s Degree, preferable in a life science or nursing, or an RN diploma. In lieu of a degree a total of 6 or 8 years relevant experience may also be considered. You also have a 3 or 4 years experience in Safety and Pharmacovigilance.
You have good verbal and written communication skills in English and a good knowledge of ICH guidelines and regulations relating to safety reporting.
Your personality: You are a bright and a quick learner whose curiosity drives you to expand your knowledge base. You are a team worker, who is quality-driven and you have a good learning curve.
To achieve the more senior level of this position you should also be flexible and able to maintain high quality under high workload and to understand complex workflows. You should be able to support Safety Associate II and Senior Technical Assistants to understand the complex workflows.
We offer a supportive and motivating environment with development opportunities that will suit your interests and needs, immediate influence on day-to-day activities, a good work-life balance as well as a competitive salary and benefits customary in the pharmaceutical industry.
We welcome you to become part of our success by sending your CV with referring to this position and the reference number 2010-55 via This e-mail address is being protected from spambots. You need JavaScript enabled to view it
ii4sm, International Institute for the Safety of Medicines Ltd.
Bollwerk-Promenade 5
CH-4051 Basel, Switzerland
Telephone: +41 (61) 865 6060
Safety Associate II and/or Senior Safety Associate
and welcome candidates who are interested in a position as Safety Associate II with the possibility to grow into the position as Senior Safety Associate according to your qualification.
The purpose of this position is to process serious adverse events and adverse events (SAE/AE) data obtained in clinical trials and spontaneous reports according to applicable regulations and guidelines, standard operating procedures (SOPs) and project requirements.
Your responsibility: In principle you review and process serious adverse events (SAE) information received from Investigator sites and adverse events (AEs) from post marketing sources. You prepare safety data reports for submissions to clients and assist in the preparation of expedited Safety Reports for submission to Regulatory Authorities. You assist in the compilation of regulatory submissions, i.e., Annual Reports, Periodic Safety Update Reports, further you assist the safety lead for projects – for the set-up, project management and client liaison- Literature searches and assistance in SAE reconciliation are also tasks among your responsibility as well as to maintain your current knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and pharmacovigilance reporting.
To achieve the more senior level of this position you should be able to
- triage SAEs/AEs
- QC data entry of SAEs/AEs
- perform the quality control review of completed individual and periodic safety reports and ensure the compliance with regulatory reporting requirements,
- prepare and/or review expedited Safety Reports for submission to Regulatory Authorities,
- prepare regulatory submissions, i.e., Annual Reports, Periodic Safety Update Reports,
- be the safety lead for projects; which includes set-up, project management and client liaison,
- prepare SAE reporting plans
- be responsible for SAE reconciliation for a study
- mentor Safety Associates and other members of the Case Processing Group involved in safety data processing
Your background: You have a Bachelor’s Degree, preferable in a life science or nursing, or an RN diploma. In lieu of a degree a total of 6 or 8 years relevant experience may also be considered. You also have a 3 or 4 years experience in Safety and Pharmacovigilance.
You have good verbal and written communication skills in English and a good knowledge of ICH guidelines and regulations relating to safety reporting.
Your personality: You are a bright and a quick learner whose curiosity drives you to expand your knowledge base. You are a team worker, who is quality-driven and you have a good learning curve.
To achieve the more senior level of this position you should also be flexible and able to maintain high quality under high workload and to understand complex workflows. You should be able to support Safety Associate II and Senior Technical Assistants to understand the complex workflows.
We offer a supportive and motivating environment with development opportunities that will suit your interests and needs, immediate influence on day-to-day activities, a good work-life balance as well as a competitive salary and benefits customary in the pharmaceutical industry.
We welcome you to become part of our success by sending your CV with referring to this position and the reference number 2010-55 via This e-mail address is being protected from spambots. You need JavaScript enabled to view it
ii4sm, International Institute for the Safety of Medicines Ltd.
Bollwerk-Promenade 5
CH-4051 Basel, Switzerland
Telephone: +41 (61) 865 6060