Senior Director of Pharmacovigilance
Scorpion Therapeutics, Rancho Santa Fe, California, United States
Role Summary
Senior Director of Pharmacovigilance responsible for design, implementation, and oversight of a global pharmacovigilance function in a biotechnology environment. Leads safety surveillance, vendor management, and regulatory submissions to support development programs, including advanced therapies. Partners with Regulatory Affairs, Clinical Operations, and Commercial teams to ensure compliant safety reporting and rapid communication of safety concerns. Responsibilities
Design, implement, and manage a robust, compliant, and scalable global pharmacovigilance system, including policies, procedures, and infrastructure suitable for cellular therapy products Develop and lead pharmacovigilance activities essential for program progression, including creation of the Risk Management Plan (RMP), Pharmacovigilance System Master File (PSMF), and required safety labeling sections Select, onboard, and oversee pharmacovigilance operations vendors and safety database providers to ensure high-quality case management, reporting, and regulatory compliance Direct and execute global safety surveillance activities, including monitoring, evaluation, and interpretation of safety data from various sources such as spontaneous reports, literature, and post-approval studies Lead signal detection and management processes, ensuring periodic review and updates to the RMP and PSMF Oversee and review aggregate safety reports (e.g., PSURs/PBRERs, DSURs) for submission to global health authorities Serve as the pharmacovigilance lead during health authority inspections (e.g., FDA, EMA) and internal audits Collaborate closely with Regulatory Affairs on submissions and labeling, with Clinical Operations/Development for seamless safety transitions, and with Commercial and Medical Affairs teams to provide expertise and training on safety reporting Chair and lead the internal Safety Review Team (SRT) for ongoing evaluation of product benefit-risk profiles Interface with vendors such as PPD and Syneos, clinical trial teams, CMO, and commercial partners to prepare safety documentation and oversee post‑marketing clinical safety surveillance Work cross‑functionally to drive business impact, team success, and continuous improvement in pharmacovigilance operations Monitor emerging safety data, regulatory trends, and therapeutic advancements in rare diseases and biologics to inform strategy Perform such other duties as may be assigned from time to time Qualifications
Required: Bachelor’s degree in a health science field (MD, PharmD, PhD, or equivalent preferred) Required: Minimum of 8+ years of progressive experience in Pharmacovigilance/Drug Safety within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership or management role Required: Mandatory prior experience successfully preparing for and executing the launch of a novel therapeutic product, preferably in the US and EU markets Required: Deep understanding of global PV regulations, guidelines, and ICH standards (e.g., FDA, EMA, MHRA, and other major health authority requirements) Required: Proven experience in establishing or significantly contributing to the implementation of a validated safety database and PV quality management system Required: Exceptional written and verbal communication skills, capable of presenting complex safety data to regulatory authorities and internal stakeholders Required: Strong understanding of regulatory compliance, including cGMP, ICH, and FDA guidelines Required: Ability to work independently, multi‑task, and meet aggressive deadlines in a fast‑paced, resource‑constrained environment Required: Willingness to travel up to 20-30% for inspections, meetings, and collaborations Required: Proficiency in Microsoft Office suite (Word, Excel, PowerPoint) Required: Equivalent combination of education and experience may be considered Preferred: Experience with cellular or gene therapy products, or other complex biologics/rare diseases Preferred: Ability to transition between strategic planning and hands‑on operational execution in a small biotech environment Preferred: Demonstrated ability to lead complex safety issues and make sound, timely decisions regarding patient safety and regulatory compliance Skills
Strong strategic thinking with hands‑on operational execution capabilities Advanced communication skills for regulatory authorities and cross‑functional teams Vendor and project management Safety data analysis and interpretation Regulatory compliance expertise (FDA, EMA, ICH, cGMP) Education
Bachelor's degree in a health science field (MD, PharmD, PhD, or equivalent preferred) Additional Requirements
Work Environment & Physical Demands: Professional office environment (San Diego, CA) or remote work setup with standard business hours, subject to flexibility for global interactions; ability to sit for extended periods during meetings and computer work; occasional travel for conferences/site visits
#J-18808-Ljbffr
Senior Director of Pharmacovigilance responsible for design, implementation, and oversight of a global pharmacovigilance function in a biotechnology environment. Leads safety surveillance, vendor management, and regulatory submissions to support development programs, including advanced therapies. Partners with Regulatory Affairs, Clinical Operations, and Commercial teams to ensure compliant safety reporting and rapid communication of safety concerns. Responsibilities
Design, implement, and manage a robust, compliant, and scalable global pharmacovigilance system, including policies, procedures, and infrastructure suitable for cellular therapy products Develop and lead pharmacovigilance activities essential for program progression, including creation of the Risk Management Plan (RMP), Pharmacovigilance System Master File (PSMF), and required safety labeling sections Select, onboard, and oversee pharmacovigilance operations vendors and safety database providers to ensure high-quality case management, reporting, and regulatory compliance Direct and execute global safety surveillance activities, including monitoring, evaluation, and interpretation of safety data from various sources such as spontaneous reports, literature, and post-approval studies Lead signal detection and management processes, ensuring periodic review and updates to the RMP and PSMF Oversee and review aggregate safety reports (e.g., PSURs/PBRERs, DSURs) for submission to global health authorities Serve as the pharmacovigilance lead during health authority inspections (e.g., FDA, EMA) and internal audits Collaborate closely with Regulatory Affairs on submissions and labeling, with Clinical Operations/Development for seamless safety transitions, and with Commercial and Medical Affairs teams to provide expertise and training on safety reporting Chair and lead the internal Safety Review Team (SRT) for ongoing evaluation of product benefit-risk profiles Interface with vendors such as PPD and Syneos, clinical trial teams, CMO, and commercial partners to prepare safety documentation and oversee post‑marketing clinical safety surveillance Work cross‑functionally to drive business impact, team success, and continuous improvement in pharmacovigilance operations Monitor emerging safety data, regulatory trends, and therapeutic advancements in rare diseases and biologics to inform strategy Perform such other duties as may be assigned from time to time Qualifications
Required: Bachelor’s degree in a health science field (MD, PharmD, PhD, or equivalent preferred) Required: Minimum of 8+ years of progressive experience in Pharmacovigilance/Drug Safety within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership or management role Required: Mandatory prior experience successfully preparing for and executing the launch of a novel therapeutic product, preferably in the US and EU markets Required: Deep understanding of global PV regulations, guidelines, and ICH standards (e.g., FDA, EMA, MHRA, and other major health authority requirements) Required: Proven experience in establishing or significantly contributing to the implementation of a validated safety database and PV quality management system Required: Exceptional written and verbal communication skills, capable of presenting complex safety data to regulatory authorities and internal stakeholders Required: Strong understanding of regulatory compliance, including cGMP, ICH, and FDA guidelines Required: Ability to work independently, multi‑task, and meet aggressive deadlines in a fast‑paced, resource‑constrained environment Required: Willingness to travel up to 20-30% for inspections, meetings, and collaborations Required: Proficiency in Microsoft Office suite (Word, Excel, PowerPoint) Required: Equivalent combination of education and experience may be considered Preferred: Experience with cellular or gene therapy products, or other complex biologics/rare diseases Preferred: Ability to transition between strategic planning and hands‑on operational execution in a small biotech environment Preferred: Demonstrated ability to lead complex safety issues and make sound, timely decisions regarding patient safety and regulatory compliance Skills
Strong strategic thinking with hands‑on operational execution capabilities Advanced communication skills for regulatory authorities and cross‑functional teams Vendor and project management Safety data analysis and interpretation Regulatory compliance expertise (FDA, EMA, ICH, cGMP) Education
Bachelor's degree in a health science field (MD, PharmD, PhD, or equivalent preferred) Additional Requirements
Work Environment & Physical Demands: Professional office environment (San Diego, CA) or remote work setup with standard business hours, subject to flexibility for global interactions; ability to sit for extended periods during meetings and computer work; occasional travel for conferences/site visits
#J-18808-Ljbffr