Description

We are seeking a Director, Safety Science who will report into the Vice President, Drug Safety & Pharmacovigilance. You will provide in-depth medical/scientific expertise in the safety evaluation and risk management of Celcuity products in clinical development and/or the post-marketing setting. Responsibilities include supporting Safety Physicians with safety-related tasks across commercial products and products in clinical development, acquiring knowledge of relevant drug classes and competitor safety issues, contributing to safety risk management, conducting signal detection activities, preparing safety documents, assisting with regulatory dossier submissions, representing Clinical Safety in meetings, developing departmental quality documents, responding to safety queries from third parties, preparing and presenting safety data summaries, conducting literature searches, and supporting quality systems. Qualifications include a relevant postgraduate qualification, five or more years of drug development experience, collaboration skills, data management experience, familiarity with safety databases, hands-on experience with analytical software, knowledge of pharmacovigilance, strong presentation skills, experience in the oncology therapeutic area, understanding of global clinical safety regulations, proficiency with pharmacovigilance databases, experience in regulatory safety documents, excellent communication skills, attention to detail, strong technical and analytical skills, and outstanding organizational skills.

Requirements

A relevant postgraduate qualification (e.g., MSc or equivalence in healthcare or in a Life sciences discipline, PhD is a plus or other post-graduate health professional qualifications). Five or more (5+) years of drug development experience in the pharmaceutical or related industry with at least three (3) years of experience in drug safety/pharmacovigilance. Collaborative team player with proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships. Must have at least two (2) years’ data management and analysis experience; Experience with large data base or post market databases such as FAERS, EudraVigilance is preferable. Familiar with safety databases and capable of extracting, handling data (or data mining) from databases as needed. Hands-on experience of common analytical software/tools such as Excel, (or R, Microsoft power BI and other analytical tools) and knowledge of safety analytics and relevant statistics. Possesses knowledge of pharmacovigilance and signal detection, evaluation process. Strong presentation skills, effective at summarizing and presenting the key data effectively to diverse stakeholders. Demonstrated experience in the oncology therapeutic area through clinical practice, drug development, or other relevant industry experience is a plus. In-depth understanding of global clinical safety and pharmacovigilance regulations and guidelines, including GVP, FDA, and EMA requirements. Proficiency with pharmacovigilance databases and tools such as Argus and MedDRA coding. Proven track record in preparing and reviewing regulatory safety documents, including, DSURs, and risk management plans. Excellent written and verbal communication skills. 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. Ability to work in a team or independently as required. Outstanding organizational skills with the ability to prioritize.