Associate Pharmacovigilance Manager
Are you the organizational and logistical go-getter that ensures an effective and accurate collection, database entry, review and reporting of safety data?
An oncology expert who can provide safety guidance to our clients and investigators during their clinical trials. Somebody who can assist in providing high quality comprehensive pharmacovigilance services.
Roles and responsibilities
- Collect SAE forms from sites in cooperation with CRA(s)
- Assist in the review of SAE forms received and determine if a follow-up query is required
- Contribute to the performance of initial safety review and triage of SAEs to determine seriousness, expectedness and priority, including the timeline for response
- Assist in liaising with the data management department to obtain required safety data and to provide safety input when required
- Support reconciliation of clinical and safety databases
- Collect and perform quality control of safety documents to be reported to regulatory authorities, ethical committees and sites
- Submit safety documents to regulatory authorities and ethical committees according to regulatory requirements including the generation of safety letters
- Assist in the creation/maintenance of study tracking logs for regulatory submissions
- Bachelor’s degree in health care, life sciences or related fields
- Medical & clinical knowledge
- Knowledge of Good Clinical Practice (GCP) and other applicable safety guidelines and regulations
- Experience in pharmaceutical or CRO industry; Safety or Regulatory department preferred
- Experience with a Global Safety Database
- Fluency in written and spoken English
- Knowledge of the EudraVigilance Training Program for electronic transmission of safety data
- Excellent analytical & problem solving skills
- Excellent oral & written communication & interpersonal skills
- Operates effectively in a team environment
- Ability to work under strict deadlines and changing priorities with some supervision
- Ability to establish priorities and proceed with accomplishing objectives
You will be part of SMS-oncology’s Pharmacovigilance team that provides precise safety handling for anti-cancer therapies. They are able to set up and perform all required safety handling management services (recording and reporting) in Europe and North America. Read more about this department. Read more about this department.
SMS-oncology is one of the few CROs in the world solely dedicated to oncology. With our unique business model of integrating oncology drug development affairs and clinical operations, we cover the whole value chain from trial design to the setup, management and completion of phase I to IV oncology trials. We specialize in early phase, pediatric and immuno-oncology trials.
Our goal is to be the leading oncology CRO. We believe that oncology trials require oncology experts. Our clients can rely on our expertise and our proactive, responsive and pragmatic approach. Our mission is to excel in oncology trials for the benefit of our clients and cancer patients worldwide.
SMS-oncology nurtures a high performance culture, provides continuous training, offer unique opportunities to learn, and stimulates personal and organizational development. Our high performance culture impacts our retention rate positively, as represented by our industry leading rate of ~95%.
What can SMS-oncology offer you?
- Exciting opportunities to further develop yourself in becoming an autonomous, flexible oncology expert
- A possibility to contribute to the development of innovative cancer therapies that will benefit patients and their families
- A fast growing and dynamic environment
Do you want to know more information regarding this vacancy? Please contact our recruitment team via +31 (0)20 4350580.