Executive Director, Pharmacovigilance

🕒 vor 2 Monaten

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🔴 Experte

👔 Direktor

👻 Geisterscore 13%

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• Seit 76 Tagen offen.
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SAB BIO

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2014

🧬 Biotechnologie

💊 Pharmazie

🏥 Gesundheitswesen

Biotechnology • Pharmaceuticals • Healthcare

SAB BIO ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das sich auf die Entwicklung multi-spezifischer, hochwirksamer humaner Immunglobulin G (hIgG)-Therapien konzentriert, um Immun- und Autoimmunerkrankungen zu behandeln und zu verhindern. Ziel ist es, die Diagnose und Behandlung von Typ-1-Diabetes (T1D) durch krankheitsverändernde Medikamente neu zu definieren. Gegründet im Jahr 2014 und seit 2021 an der Nasdaq (SABS) notiert, nutzt SAB BIO proprietäre Technologien der genetischen Entwicklung und Antikörper zur Generierung therapeutischer Kandidaten, ohne auf menschliche Spender oder Rekonvaleszenz-Plasma angewiesen zu sein. Das Unternehmen hat sieben klinische Studien durchgeführt, in denen etwa 700 Personen in verschiedenen therapeutischen Bereichen dosiert wurden, und berichtet über keine Patienten mit Serumkrankheit oder neutralisierenden Anti-Drug-Antikörpern in seiner Sicherheits- und Immunogenitätsdatenbank. Der führende Kandidat, SAB-142, zielt darauf ab, das Fortschreiten von T3D im Stadium 3 zu verzögern und möglicherweise zu verhindern.

Beschreibung

• Lead and execute all pharmacovigilance activities for Phase 3 and registrational biologics programs • Ensure compliance with ICH, FDA, EMA, and other applicable regional requirements • Oversee global signal detection, evaluation, management, MedDRA coding review, and benefit-risk assessment updates • Manage safety data receipt, processing, and reporting workflows with CROs, data management, and clinical operations • Serve as subject-matter expert and primary PV contact for clinical, regulatory affairs, and medical affairs teams • Maintain and enforce the global safety database and adverse event reporting infrastructure • Oversee vendor relationships and PV service partnerships • Author or oversee Integrated Safety Summaries (ISS) and Integrated Summaries of Efficacy (ISE) for BLA and MAA submissions • Oversee end-to-end safety labeling strategy for biologics • Lead Clinical Study Report safety sections, including narratives, adverse event tabulations, and laboratory data analyses • Prepare and manage PSURs, PBRERs, and DSURs • Prepare Risk Management Plans and Risk Evaluation and Mitigation Strategies • Respond to health authority safety questions during regulatory reviews • Design and implement systematic pharmacovigilance surveillance programs and safety monitoring plans • Prepare signal assessment reports and escalate findings to the Safety Monitoring Committee or DSMB • Interpret safety trends with clinical pharmacology and biostatistics teams • Support post-marketing commitments and Phase 4 safety studies • Partner with Clinical and Regulatory Affairs on global filing strategy and PV regulatory timelines • Represent PV in Health Authority meetings and advisory committee preparations • Collaborate with Medical Affairs and Commercial teams on labeling updates and post-approval safety activities • Build and mentor a small PV team or oversee contract resources as the company scales • Establish and maintain SOPs, work instructions, and quality standards • Conduct oversight audits and ensure GVP compliance • Represent PV on the Clinical Development Team and participate in Program Team leadership meetings • Travel for team meetings, Health Authority interactions, investigator meetings, and conferences

🎯 Anforderungen

• Doctor of Medicine (MD) degree from an accredited institution is required • 12+ years of progressive pharmaceutical/biotech industry pharmacovigilance experience • At least 5 years in a senior role with direct accountability for late-phase global biologics PV programs • Demonstrated hands-on authorship of Integrated Safety Summaries (ISS) submitted in at least one BLA or MAA • Extensive experience authoring CSR safety sections, DSURs, and PSURs/PBRERs for biologic compounds in global development • Deep command of ICH guidelines (E2A–E2E, E6, E8, M4E), FDA/CDER and EMA GVP Module requirements, and regional pharmacovigilance regulations (EU, US, Japan, and other ICH regions) • Extensive experience with signal detection methodologies, benefit-risk assessment frameworks, and safety narrative writing • Proven track record managing CRO/vendor PV relationships and safety database oversight (Argus, ARISg, or equivalent) • Experience with BLA or MAA approval for a biologic • Familiarity with rare disease, orphan drug, or first-in-class biologic programs • Experience presenting to Health Authorities (FDA, EMA) and participation in Advisory Committee proceedings • Familiarity with REMS design and implementation or EU RMP preparation • Knowledge of pharmacoepidemiology methodologies and real-world evidence applications in safety assessment • Exceptional scientific and medical writing ability • Strong analytical and critical thinking skills • Ability to independently evaluate complex safety signals and formulate evidence-based recommendations • Ability to engage clinical, statistical, and regulatory colleagues at a peer level • Excellent project management skills • Demonstrated leadership and cross-functional collaboration • Comfortable operating with limited infrastructure and high personal accountability • Regularly required to walk, stand, and sit • Must regularly lift and/or move up to 10 pounds

🏖️ Vorteile

• Home office working environment • Domestic and international business travel (estimated 10–20%) • Reasonable accommodations in compliance with the Americans with Disabilities Act of 1990 • Equal employment opportunity protections • SMS/text message updates regarding the job application

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