Position Summary:
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.
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.
Qualifications:
- Bachelor’s degree in health or life sciences field required. Degree in nursing, pharmacy, or other healthcare related field preferred.
- 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.
About Us:
Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company’s first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.
The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.
Celcuity is an Equal-Opportunity Employer.
Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $95,000 – $110,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
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