Drug Safety Specialist

Celcuity•Minneapolis, MN

7d•$95,000 - $110,000•Onsite

About The Position

Reporting to the Associate Director, Drug Safety & Pharmacovigilance, the Drug Safety Specialist will focus on overseeing all aspects of serious adverse event case processing and reporting for Celcuity products in clinical trials. The incumbent may serve as a liaison to CROs and company personnel for safety-related issues and will work in collaboration with colleagues from cross-functional departments to accomplish tasks and meet deliverables.

Requirements

Bachelor’s degree in health or life sciences field required.
2-5 years of experience in clinical trial drug safety operations or a combination of clinical trial and post-marketing drug safety operations experience in a biotechnology, pharmaceutical company, and/or CRO.
Working knowledge of ICH/GCP guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.
Excellent written and verbal communication skills, with ability to influence and build credibility at all levels.
Strong interpersonal skills for interacting with employees and leaders across various levels and functions.
Attention to detail and ability to manage multiple processes and documentation requirements.
Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint.
Experience with Argus, electronic data capture (EDC), and trial master file (TMF) system-based software required.
Ability to work in a team or independently as required.
Outstanding organizational skills with the ability to prioritize.
Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
Maintain a positive, approachable and professional attitude.

Nice To Haves

Degree in nursing, pharmacy, or other healthcare related field preferred.

Responsibilities

Assists in the management of the Safety Department mailbox and tracking documents for Celcuity products and safety requests to ensure timely completion.
Performs quality reviews on safety cases to ensure completeness and accuracy of case presentation and medical coding and provides timely feedback to safety vendors.
May generate safety queries to complete and clarify SAE case information and works with the safety vendor to determine when cases are complete and ready to close.
Manages various types of reconciliations between safety and clinical vendors according to reconciliation plans and between Celcuity and business partners according to exchange agreements.
Reviews and provides input on operational reports provided by safety vendor and implements process improvements, as needed.
Management, quality review, and provision of safety documents for the trial master file
Supports the Safety Department during meetings with agenda development, drafting meeting minutes and tracking action items to completion.
Assists or leads safety-related activities required for study start-up and close out including but not limited to SAE report and pregnancy report development, safety plan development, and process development.
Collaborates with internal and external stakeholders to communicate the need for expedited safety reporting and tracks cases to ensure on-time reporting.
Participates in the development of controlled documents.
Supports activities required in association with safety data exchange agreements.
Supports and participates in audits and inspections, including preparation activities.
Other duties as assigned.