Director, Safety Scientist, Pharmacovigilance

🕒 il y a 16 jours

🇺🇸 États-Unis – Télétravail

💵 $220 000 - $240 000 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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MapLight Therapeutics, Inc.

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11 - 50 employés

🏥 Santé

💼 Conseil

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

MapLight Therapeutics, Inc. est une entreprise de biotechnologie dédiée à la transformation du traitement des troubles cérébraux, incluant des conditions telles que la schizophrénie, la maladie d'Alzheimer et les troubles du spectre autistique. Elle exploite des technologies avancées comme l'optogénétique et la transcriptomique pour identifier les circuits neuronaux spécifiques impliqués dans ces troubles, dans le but de développer des thérapies ciblées capables d'améliorer significativement les résultats pour les patients. Leur plateforme de découverte innovante soutient un pipeline robuste d'essais cliniques et précliniques axés sur la réponse aux besoins médicaux non satisfaits dans les affections du système nerveux central.

Description

• Manage safety surveillance and signal detection activities, including periodic review of aggregate safety data, safety surveillance team meetings, and signal documentation • Represent Pharmacovigilance at clinical study teams for assigned products • Develop signal assessment reports under the oversight of the Program Safety Lead • Collaborate with PV Operations on timely and accurate medical review of ICSRs for assigned clinical studies • Develop and contribute to safety risk management plans across the product lifecycle • Develop and manage periodic reports, including DSUR and PBRER • Contribute data analysis and author safety sections for regulatory submissions and responses • Contribute to safety surveillance and risk management SOPs and templates • Collaborate with clinical study teams on safety surveillance deliverables, including IB, RSI, Protocol, and briefing documents • Participate in PV audits and inspections • Represent Pharmacovigilance in internal and external committees and activities • Collaborate with Program Safety Lead, program team members, PV Operations, and CROs to ensure proactive safety surveillance compliant with global regulations • MapLight Therapeutics is a clinical-stage biotech company focused on drug discovery for central nervous system disorders, using optogenetics, in vivo physiology, and spatial transcriptomics

🎯 Exigences

• Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science • Minimum 10 years of pharmacovigilance experience within the biopharmaceutical industry • At least 3 years of direct clinical/patient care experience • Competence in safety data reviews, aggregate report preparation, signal detection, and risk management plans for investigational and/or post-marketed products • Experience with MedDRA and drug coding reviews • Expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes • Experience in individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections • Ability to travel as needed, up to 10% • Preferred: Post-graduate training in epidemiology (e.g. MPH) • Preferred: Safety surveillance and risk management experience in neuroscience, psychiatry or neurodegenerative disease • Exceptional communication and cross-functional collaboration skills • Strategic thinking and ability to translate complex safety data into actionable insights • Ability to work within a growing organization and help it evolve • Ability to engage in open, constructive and continuous dialogue with stakeholders • Highly motivated, self-driven and dependable • Commitment to MapLight's Core Beliefs and Values

🏖️ Avantages

• Annual bonus opportunity • Medical insurance • Dental insurance • Vision insurance • Life insurance • AD&D insurance • Short-term disability • Long-term disability • 401(K) plan with match • Stock options • Flexible non-accrual paid time off • Parental leave • Up to 10% travel for corporate and departmental meetings

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