Director, Safety Science (Patient Safety & Pharmacovigilance)

This position will be on-site in one of the following locations: Dallas, TX / Miami, FL / Princeton, NJ

*Relocation support will be considered for this role

Overview of Role

:The Director of Safety Science reviews, leads, strategizes and executes on all day-to-day Safety work and deliverables; including, responses to regulatory inquiries, regulatory-required periodic reporting and assessment of safety risks

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Role and Responsibilitie

• s:Perform signal management activities (including signal detection) using various tools and programs (e.g., MS Excel, PowerPoint, Tableau, etc
• .)Work with Pharmacovigilance vendor to generate safety listings from the Safety Databa
• seInteract, communicate and collaborate effectively with cross-functional colleagues and development partners in a professional mann
• erApply medical knowledge to effectively analyze safety data from various sources (e.g., toxicology, pre-clinical, clinical, post-approval, literature, etc
• .)Prepare presentations and effectively communicate (verbally and in writing) important safety concerns, and risk management evaluations when necessary to various internal stake holders at the direction of Safety Science Exec. Director, Sr, Director, or
• VPManage literature review for investigational products, and eventually for marketed products when necessa
• ryCoordinate, and contribute to authoring, review and submission of periodic safety reports (e.g., DSUR, PADER, PBRER reports) and collaborate with subject matter experts / functions to provide necessary periodic report conte
• ntResponsible for providing, preparing, authoring, or reviewing safety sections / content of regulatory response documents, investigator brochures (IB), referenced safety information (RSI) and RSI justification documents, clinical trial protocols, informed consent forms (ICFs), and clinical report forms (CRF
• s)Provide and review safety data for or contribute to the creation of regional product labels (package inserts) and company core data sheet (CCD
• S)Work with Medical Writers and Biometrics team to plan for Tables, Figures and Listings (TFLs) and content to be included in clinical study reports (CSRs) and submission documents (e.g., summary of safety document module 2.7.4). Author and review sections within these documents when required within established delivery timeline
• s.Coordinate the writing of CSR Safety Narratives with Medical Writing Team or Contract
• orResponsible for providing, preparing, authoring, or reviewing safety sections / content of risk management plans (RMP
• s)Work with Qualified Person Responsible for Pharmacovigilance (QPPV) officer and office once established, and support creation of the Pharmacovigilance system master file (PSM
• F)Schedule, host and prepare slides for scheduled and ad-hoc Drug Safety Committee (DSC) meetin
• gsLead / Assist in developing, implementing, and supporting policies, standard operating procedures (SOPs), tools, etc., pertaining to Safety Science activities when needed; and contribute to cross-functional process development when need
• edSupport Pharmacovigilance (PV) audits and inspections by participating in audit preparedness activities and serving as subject matter expert during regulatory inspections in collaboration with team membe
• rsEnsures global regulatory compliance for all Serious Adverse Events (SAEs), signal management, risk management, and other PV related activiti
• esAll other duties as assign

edExperience, Education and Specialized Knowledge and Skill

• s:MD, PharmD, PhD or MSN requir
• edStrong knowledge and understanding of domestic and international safety reporting and pharmacovigilance requirements and signal detection (e.g., FDA and EU regulations, and guidance document
• s)8 years of drug safety experien
• ceAbility to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreemen
• tsKnowledge of working with a safety database (i.e., Argus) for retrieval of safety informatio
• n.Experience in oncology drug development highly desirab
• leStrong computer and database skil
• lsAttention to detail, accuracy and confidentiali
• tyClear and concise oral and written communication skil
• lsExcellent organizational skil
• lsCritical thinking, problem solving, ability to work independent
• lyMust be able to effectively multi-task and manage time-sensitive and highly confidential documen
• tsCommunicate effectively and articulate complex ideas in an easily understandable w
• ayPrioritize conflicting deman
• dsWork in a fast-paced, demanding and collaborative environme