Who We Are
Synteract is a global full-service contract research organization (CRO) with a successful three-decade track record supporting biotechnology, and pharmaceutical companies.
With our mission of Bringing Clinical Trials to Life, we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations.
Our mission is to support the innovation and development of better therapies in healthcare. Position Overview The Senior Safety Surveillance Associate is responsible for the processing of safety reports from clinical sites, spontaneous reporters, and other entities, as applicable, according to the Company’s procedures and global drug safety regulations and guidelines.
Serves as the Safety Lead for client study(ies) / project(s). Specific tasks would include :
Discusses safety project needs with client, performs project start up and close-out activities, and represents safety on the project team.
Reviews and analyzes safety report information for completeness, accuracy and regulatory reportability requirements.
Evaluates safety case data with an emphasis on medical presentation, conducts discussions regarding specific patient case data with health care practitioners, Sponsors, and business partners;
determines regulatory reporting requirements based upon case data, product information, and FDA or ICH guidelines and regulations.
Prepares safety reports, including preparation of narrative summary, and generation of reports for submission to Competent Authorities.
Identifies missing / discrepant data (medical and documentation issues), writes queries, addresses queries with site personnel and / or reporter, evaluates query responses, and resolves queries when complete.
Determines configuration specifications for 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.
Prepares safety information / tables and / or reports for clients and / or regulatory agencies.
Reconciles safety data with applicable sources.
May contribute to the development of internal processes, which integrates safety monitoring and processing of safety data with management of data in study specific clinical databases.
Provides operational and technical guidance and direction to colleagues.
Participates in audit preparation and conduct of audits.
May present safety information to clients, deliver presentations at Investigator's Meetings, and participate in meetings with potential clients.
Provides operational and technical guidance and direction to colleagues; coaching and training to lower level personnel
Bachelor’s degree in nursing (B.S.N.), Registered Nurse (R.N.), Doctor of Pharmacy, Health Science degree or other related field of study and 5+ year’s safety surveillance experience or equivalent combination of education and experience.
Extensive knowledge of medical terminology and of GCPs, ICH guidelines, and global drug safety and clinical trial regulations.
Intermediate level proficiency in Microsoft Word, Excel and Outlook; basic proficiency in PowerPoint.
The ability to learn Safety database software and related software functionality.
Effective verbal and writing skills; English + local language, if relevant.