(Senior) Safety Surveillance Associate (f/m) (office-based – Germany/Munich)Shared Work – Shared Vision: The way we do business, a promised standard that includes ongoing support from a specialized team dedicated to meeting or exceeding our clients expectations.
SynteractHCR is an international CRO located in EU, RUS, US and South America. As we are growing we are looking for a committed person to join our team in Munich. We are looking for a dedicated Drug Safety Professional who will provide safety surveillance services for international Clinical Trials. We offer you a challenging and rewarding job opportunity in a fast moving, flexible environment and a highly motivated team.
- Reviews and analyzes safety report information for completeness, accuracy and regulatory reportability requirements.
- Evaluates safety case data with an emphasis on medical presentation
- Prepares safety reports, including preparation of narrative summary.
- Identifies missing/discrepant data (medical and documentation issues), writes queries, addresses queries with site personnel, evaluates query responses, and resolves queries when complete.
- May contribute to configuration specifications of the safety database, including updates.
- Performs coding of adverse event and medical history terms, concomitant medications, and laboratory test names within the safety database.
- Performs clinical review of data from the Case Report Forms with an emphasis on safety.
- Reviews safety information/tables and/or reports for clients and/or regulatory agencies.
- Reconciles safety data with applicable sources.
- Bachelor's degree in life sciences, medical degree or a related field of study
- 3+ years drug safety/ safety surveillance experience in a CRO environment
- Good understanding of medical terminology and of GCPs, ICH guidelines and global drug safety and drug development process and regulations
- Understanding safety databases and/ or ability to learn safety database software and related software functionality
- Detail orientated, structures, deadline orientated and ability to keep an overview
- Intermediate level proficiency in Microsoft Word, Excel, and Outlook; basic proficiency in PowerPoint and effective verbal and writing skills
- Excellent English language skills, good German language skills (written and oral)