Director, Safety Scientist, Pharmacovigilance

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $220k - $240k / year

⏰ Full Time

🔴 Lead

👔 Director

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MapLight Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

MapLight Therapeutics, Inc. is a biotechnology company dedicated to transforming the treatment of brain disorders, including conditions such as schizophrenia, Alzheimer’s disease, and autism spectrum disorder. They leverage advanced technologies like optogenetics and transcriptomics to identify specific neural circuits involved in these disorders, aiming to develop targeted therapeutics with the potential to significantly improve patient outcomes. Their innovative discovery platform supports a robust pipeline of clinical and preclinical trials focused on addressing significant unmet medical needs in central nervous system conditions.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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