Cara Therapeutics, Inc. is searching for a full-time Drug Safety Associate with experience to manage receipt and follow up of SAE reports from clinical sites, as well as book-in the cases in the safety database. Oracle Argus Safety database experience; knowledge of medical terminologies and the clinical trial process are highly desirable for this position.
Book-in and perform case processing of serious ICSRs and other qualified case reports in the safety database.
Manage and track receipt of initial and follow-up reports from study sites.
Monitor and track reports in the safety desk.
Manage and track report submission and distribution.
Manage and track compliance with Pharmacovigilance agreements.
Support aggregate report preparation activities.
Participate and support other functional unit activities as assigned.
Consistently apply case processing and archiving policies and practices per Company SOP.
Coordinate activities of Drug Safety Functional Unit.
Support and participate in inspection preparedness activities.
Must have the ability to multi-task and work with minimal supervision.
Must be able to solve routine problems and to surface issues constructively.
Must be able to make basic decisions with understanding of the consequences.
Achieve personal objectives while meeting departmental standards of performance.
Receptive to acquiring new knowledge and learning new skills.
Highly organized with attention to detail.
Ability to work within deadlines and prioritize cases accordingly.
Great interpersonal skills.
Fluent in written and spoken English.
Safety database case processing experience, preferably Oracle Argus.
Basic knowledge of relevant FDA/GCP/ICH guidelines and AE reporting requirements.
Experience with MedDRA and WHODrug coding dictionaries.
Basic understanding of clinical trial operation.
Proficiency with use of Adobe Acrobat (Reader and Writer), Microsoft XL and Microsoft Word.
Cara Therapeutics is a clinical-stage biotechnology company located in Stamford, CT focused on developing and commercializing new chemical entities designed to fundamentally change the way acute pain, chronic pain and pruritus are managed. We aim to achieve this by developing new products that selectively target the body’s peripheral kappa opioid receptors. Cara is developing a novel and propriet...ary class of product candidates that target the body’s peripheral nervous system and have demonstrated initial efficacy in patients with moderate-to-severe pain and pruritus (itch) without inducing many of the undesirable side effects typically associated with currently available pain and itch therapeutics.