Director, Drug Safety & Pharmacovigilance - Safety Scientist (Hybrid or Remote) (San Diego)

Reference: 628997Posted: 2026-07-24Location: San Diego, CaliforniaCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on apply.placed-app.com Summary:The Director, Drug Safety & Pharmacovigilance (DSPV) Safety Scientist will provide strategic and operational leadership for safety science activities across the company’s clinical development and commercial product portfolio. This role is responsible for leading safety signal detection and management, aggregate safety reporting, benefit-risk evaluation, safety surveillance, risk management activities, and regulatory safety responses. The Director, DSPV Safety Scientist will serve as the safety science lead for assigned products and programs, providing expert medical and scientific guidance while ensuring compliance with global pharmacovigilance regulations and company policies. 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 objectivesLeads ongoing benefit-risk evaluations and recommends appropriate risk mitigation strategies for assigned products, programs, or therapeutic areasRepresents DSPV on cross-functional governance committees, development teams, and strategic initiativesPerforms medical review of ICSRs from clinical trials and postmarket reports (coding, expectedness, causality, seriousness, and narratives) to ensure quality and accuracy of reportsParticipates in Medical Data Review, including coding review of clinical study dataLeads safety signal management activities of assigned products, and oversight of vendor delegated to conduct signal detection, if applicableLeads 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 CSRsReviews tables, figures, and listings, and safety analyses supporting regulatory submissionsEnsures ongoing assessment of risk minimization (such as REMS, RMPs, etc.) effectiveness and regulatory complianceServes as a subject matter expert during regulatory inspections, audits, and due diligence activitiesLeads inspection readiness efforts for Safety Science and safety surveillance functionsProvides strategic oversight of pharmacovigilance vendor supporting safety science activitiesCollaborates with Clinical Development, Biostatistics, Regulatory Affairs, Medical Affairs, Medical Writing, and Quality to ensure alignment on safety strategies and deliverablesMay directly manage other Pharmacovigilance personnelContributes 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 InstructionsAdditional duties assigned as needed Education/Experience 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 preferredMinimum 10+ years of experience in Drug Safety/Pharmacovigilance for a biotech/ pharmaceutical company in clinical and postmarketing environments8+ years of progressively increasing leadership responsibility within Safety Science or related fieldExperience leading safety surveillance, signal detection, aggregate reporting, and benefit-risk assessmentsSignificant experience authoring and/or overseeing DSURs, PSURs/PBRERs, PADERs, and RMPsStrong understanding of global pharmacovigilance regulations including FDA, EMA, ICH, MHRA, and other international requirementsStrong knowledge of MedDRA, WHO Drug Dictionary and safety databases (e.g ARGUS, ARISg, etc) Comp based on experience/level – $189,000.00 – $246,000.00 range