[Hiring] Senior Medical Director, Drug Safety and Pharmacovigilance @Celcuity

Role Description

We are seeking Senior Medical Director, Drug Safety and Pharmacovigilance who will report to the Vice President, Drug Safety and Pharmacovigilance. You will be responsible for:

• Medical triage
• Medical safety assessment of case reports
• Signal detection
• Risk management
• Periodic reports
• Agency queries for marketed products and products under development

Together with the safety team, the Medical Director will develop and maintain:

• Safety data exchange agreements
• Safety system
• Policies and procedures
• Quality and regulatory compliance
• Inspection readiness
• Vendor oversight
• Commercial launch planning
• Training of internal and external stakeholders

Responsibilities include:

• Medical oversight of safety vendor(s) to ensure effectiveness, quality, and compliance of all outsourced activities
• Support timely triage and narratives for timely case reporting to agencies and for periodic safety reports (e.g., DSURs, PADERs, etc.) in collaboration with other cross-functional teams
• Provide day-to-day medical support for the Safety Operations team and updates to internal and external stakeholders
• Review incoming adverse event reports to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices
• Support safety inspection readiness activities in collaboration with department leadership
• Support the requirements of Safety Data Exchange Agreements with Celcuity partners and ensure compliance with the agreed upon terms and timelines
• Review and provide input on the safety sections of clinical documents, including but not limited to the safety reporting section of protocols, Investigator Brochures, and Informed Consents
• Support the development of internal and external (with vendors) key performance indicators and metrics to track performance
• Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
• Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed
• Serve as the Safety subject matter expert for internal audits and global inspections
• Other duties as assigned

Qualifications

• 10+ years of drug safety/pharmacovigilance experience in a sponsor company or a combination of sponsor and CRO experience
• Medical degree; training in medical or radiation oncology, hematology or related field preferred
• Comprehensive knowledge of global drug safety related regulations and work practices
• Extensive experience with commercial safety databases (Argus or ARIS-G) and electronic data capture systems
• Experience with the preparation of aggregate reports (i.e., DSUR, PSUR/PBRER, PADER, RMP, ISS) and ICF and IB updates
• Excellent knowledge of MedDRA and WHO Drug coding practices
• Excellent verbal communication and presentation skills with ability to write clearly and concisely
• Strong project management skills with the ability to prioritize to meet required timelines
• Ability to multitask and prioritize under tight timelines while providing attention to detail and high-quality work in a dynamic environment

Requirements

• 3+ years of clinical physician experience in treatment of solid cancers in a multidisciplinary environment (preferred)
• Fluency in written and spoken English
• Strong scientific and analytical skills with strong ability to interpret and communicate medical safety data from various sources
• Experience with audit readiness/preparedness activities
• Competency in presenting data, obtaining, analyzing, and reporting safety data
• NDA and MAA filing experience
• Experience with challenging current practices to drive improvement and innovation
• Ability to work in a team or independently as required
• Maintain a positive, approachable and professional attitude

Benefits

• Anticipated base pay range: $338,000 - $366,000
• Annual performance incentive bonus
• New hire equity package
• Medical, dental, vision insurance
• 401(k) match
• PTO and paid holidays