Senior Medical Director, Drug Safety and Pharmacovigilance

Position Summary

We are seeking Senior Medical Director, Drug Safety and Pharmacovigialnce 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, and 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, and training of internal and external stakeholders.

Responsibilities

• Responsible for 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 provide updates to internal and external stakeholders, as required.
• Reviews 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.
• Reviews and provides 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
• Serves 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 in drug safety/pharmacovigilance.
• 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.

Preferred

• 3+ years of clinical physician experience in treatment of solid cancers in a multidisciplinary environment.
• Fluency in written and spoken English
• Strong scientific and analytical skills with strong