Junior Safety Specialist
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
Are you ready to join a game-changing company? In this role you’ll be fully employed by Syneos Health and will enjoy our very competitive primary and secondary benefits. Being part of our Strategic Resourcing team, you will be fully assigned to our client with offices in Zaventem.
The Junior Safety Specialist assists the CSU Safety Lead in defined Pharmacovigilance tasks and safety documentation, including the reporting of safety events (Individual Case Safety Reports - ICSRs), related to clinical studies, according to Local Regulations and Corporate and Local Quality Documents (QDs).
The main tasks of the Junior Safety Specialist are:
- Ensure that minimum criteria for received cases are completed, supporting documents translated into English (if applicable), and forwarded to GPV, in a timely manner, according to Corporate and Local Quality Documents (QDs).
- Ensure that GPV/MT are informed of all questions/clarifications/requests for supporting documents already requested to follow up by the MT with the investigators and make sure of answer in due time.
- Ensure that all questions coming from GPV are received and distributed to the corresponding monitoring team members for follow up with the investigators and ensure that answers are forwarded to GPV in due time, as per QDs timelines for ICSRs reporting.
- Assists in the handling and distribution of safety information (ICSRs, DILs and Periodic Safety Reports), and ensures shipment, per global & local QDs, and, as applicable according to local regulation, to the following recipients: Investigators – Ethics Committees – Health Authorities
- reception by e-CRF (fax) and identification of the case
- check specific requirements form and minimal information ICSR
- review AE and contact CRA (if available/ necessary) or CSU- SL
- Complete SAMS tracking system
- Translation of keywords/summary of hospital reports
- Ensure review of keywords/summary by MA/ CSU SL/ TM
- Send case information to GPV
- Reception of acknowledgement of receipt
- Files electronically
- Tracking questions of GPV in SAMS
- Relevant master degree or equal by experience
- professional experience in Drug Safety, Clinical Development or Clinical Research is an advantage
- Good knowledge of local and international regulations, and Good Clinical Practices.
- Good knowledge of Word and Excel
- Fluent in French, Dutch and English
Please contact one of our Benelux recruiters, Eveline Wigtman or Irene Houtsma and we would be more than happy to speak about this opportunity.