Director, Drug Safety & Pharmacovigilance - Safety Scientist

Responsibilities

• Provides strategic leadership for safety surveillance and safety science activities across assigned development and commercial products, including development and implementation of safety monitoring strategies aligned with regulatory requirements and business objectives
• Led ongoing benefit-risk evaluations and recommends appropriate risk mitigation strategies for assigned products, programs, or therapeutic areas
• Represents DSPV on cross-functional governance committees, development teams, and strategic initiatives
• Performs medical review of ICSRs from clinical trials and postmarket reports (coding, expectedness, causality, seriousness, and narratives) to ensure quality and accuracy of reports
• Participates in Medical Data Review, including coding review of clinical study data
• Leads safety signal management activities of assigned products, and oversight of vendor delegated to conduct signal detection, if applicable
• Leads and/or contributes to the planning, preparation, writing, review and QC of aggregate safety reports (e.g. PADER, PSUR/PBRER, DSUR)
• Reviews and contributes to safety sections of key study documents such as Investigator Brochures, protocols, statistical analysis plans, informed consent forms, and CSRs
• Reviews tables, figures, and listings, and safety analyses supporting regulatory submissions
• Ensures ongoing assessment of risk minimization (such as REMS, RMPs, etc.) effectiveness and regulatory compliance
• Serves as a subject matter expert during regulatory inspections, audits, and due diligence activities
• Leads inspection readiness efforts for Safety Science and safety surveillance functions
• Leads and/or contributes to the development of risk management plans and product labels (e.g., USPI, EU SmPC)
• Leads development and continuous improvement of DSPV SOPs and/or Work Instructions
• Contributes to the development of risk management plans and product labels (e.g., USPI, EU SmPC)
• Leads development and continuous improvement of DSPV SOPs and/or Work Instructions

Requirements

• Bachelor’s degree in healthcare professional or related field required. Equitable combination of skills and relevant experience are also considered.
• RN, PharmD, PA or NP, or equivalent preferred
• Minimum 10+ years of experience in Drug Safety/Pharmacovigilance for a biotech/pharmaceutical company in clinical and postmarketing environments
• 8+ years of progressively increasing leadership responsibility within Safety Science or related field
• Significant experience authoring and/or overseeing DSURs, PSURs/PBRERs, PADERs, and RMPs
• Strong understanding of global pharmacovigilance regulations including FDA, EMA, ICH, MHRA, and other international requirements
• Strong knowledge of MedDRA, WHO Drug Dictionary and safety databases (e.g ARGUS, ARISg, etc)