Vice President, Drug Safety – Pharmacovigilance

Job not on LinkedIn

November 9

❄️ Minnesota – Remote

Although this job is listed in Minnesota, this company may be open to hiring remote in other states.

💵 $380k - $440k / year

⏰ Full Time

🔴 Lead

👔 Vice President

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Celcuity

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Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Ensure competent medical evaluation of all relevant safety information • Proactively interact with clinical trial investigators and other medical staff • Work with PV vendor and internal safety team to develop a system for post-marketing safety surveillance • Lead Celcuity’s Safety Management Team and oversee all risk-benefit assessments • Collaborate cross-functionally with Clinical Development, Regulatory, Clinical Operations, Medical Affairs, Quality, and Commercial teams • Serve as the company’s senior safety spokesperson in regulatory inspections and audits • Lead the design and continuous improvement of the company’s PV system • Contribute to and ensure timely submission of expedited safety reports • Oversee the pharmacovigilance quality management system • Develop and maintain comprehensive PV agreements • Contribute to the development of company documents such as SOPs, clinical study reports, and safety plans • Mentor and develop the drug safety and pharmacovigilance team • Oversee the QPPV and PSMF development and maintenance • Develop and manage the PV budgets and staffing projections

🎯 Requirements

• Medical Doctor (MD) or equivalent • At least three (3) years of clinical experience • Ten plus (10+) years of progressive experience in pharmacovigilance or drug safety • At least five (5) years in senior leadership roles • Deep knowledge of U.S. FDA regulations, ICH guidelines, EU GVP modules, and global PV legislation • Proven ability to manage large global teams • Commercial launch experience required • Strategic thinker with strong leadership presence and excellent communication skills • Expertise in benefit-risk assessment, signal detection methodologies, and risk management planning • Strong decision-making ability under complex and time-sensitive circumstances • Proven track record in building and scaling-up global PV systems • Excellent written and verbal communication skills • Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint • Experience with Oracle Argus or similar commercial safety database required • Must be a self-starter and willing to play a hands-on role in developing the company’s PV function

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays • Annual performance incentive bonus • New hire equity package